Elastic Study List
Endpoint to query studies
The studies endpoint gives access to the studies data. A study is a container of consistent pharmacokinetics data. This container mostly contains data reported in a single scientific paper.
GET /api/v1/studies/?format=api
{ "current_page": 1, "last_page": 34, "next_page_url": "https://pk-db.com/api/v1/studies/?format=api&page=2", "prev_page_url": null, "data": { "count": 674, "data": [ { "pk": "1", "sid": "PKDB00213", "name": "Lowenthal1976", "licence": "closed", "access": "public", "date": "2019-10-12", "group_count": 4, "individual_count": 13, "intervention_count": 1, "output_count": 178, "output_calculated_count": 48, "subset_count": 9, "timecourse_count": 9, "scatter_count": 0, "reference": { "pk": 1, "study": { "sid": "PKDB00213", "name": "Lowenthal1976" }, "pmid": "1263112", "sid": "1263112", "name": "Lowenthal1976", "doi": null, "title": "Pharmacokinetics of acetaminophen elimination by anephric patients.", "abstract": "The pharmacokinetics of acetaminophen elimination were determined in five surgically anephric and five physiologically anephric patients on an interdialysis day, and in three normal adult volunteers. There was no significant difference in the biologic half-life and no apparent difference in the volume of distribution of acetaminophen between the three groups of subjects but the anephrics, unlike the normal subjects, showed pronounced accumulation of acetaminophen glucuronide and sulfate in plasma. The apparent volume of distribution for conjugated acetaminophen is considerably smaller than that for the unmetabolized drug even though neither acetaminophen nor its glucuronide or sulfate is significantly bound to plasma proteins. The results of this study indicate that the kidneys do not contribute significantly to the elimination of acetaminophen in man. Sin ce acetaminophen is eliminated largely by conjugation with glucuronic acid and sulfate, it can be concluded that the kidneys do not contribute significantly to the formation of these metabolites.", "journal": "The Journal of pharmacology and experimental therapeutics", "date": "1976-07-06", "authors": [ { "pk": 1, "first_name": "D T", "last_name": "Lowenthal" }, { "pk": 2, "first_name": "S", "last_name": "Oie" }, { "pk": 3, "first_name": "J C", "last_name": "Van Stone" }, { "pk": 4, "first_name": "W A", "last_name": "Briggs" }, { "pk": 5, "first_name": "G", "last_name": "Levy" } ] }, "reference_date": "1976-07-06", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 3.7, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [], "descriptions": [ { "pk": 1, "text": "Five surgically anephric patients, five physiologically anephric patients (creatinine clearance < 5 ml/min) and three normal volunteers (members of the medical staff) gave their informed consent and participated in this investigation. The patients were maintained on regular hemodialysis, three times a week, and are described in table 1. They were studied on an interdialysis day" } ], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" } ], "groupset": { "descriptions": [], "comments": [], "groups": [ 1, 2, 3, 4 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 ] }, "interventionset": { "descriptions": [], "comments": [ { "pk": 3, "username": "jbrandhorst", "text": "All subjects received a single oral dose of acetaminophen, 1 g per 1.73 m2 of body surface area (Tylenol elixir) in the morning on an empty stomach. Food was permitted after 1 hour." } ], "interventions": [ 2 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 218, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 237, 238, 239, 240, 241, 242, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234, 235, 236, 255, 256, 257, 258, 259, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254, 219, 220, 221, 222, 223, 224, 267, 268, 269, 270, 271, 272, 279, 280, 281, 282, 283, 284, 291, 292, 293, 294, 295, 296, 300, 301, 302, 309, 310, 311, 312, 313, 314, 321, 322, 323, 324, 325, 326, 260, 330, 331, 332, 339, 340, 341, 342, 343, 344, 351, 352, 353, 354, 355, 356 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 1, 2, 3, 4, 5, 6, 7, 8, 9 ] } }, { "pk": "2", "sid": "4942784", "name": "Levy1971b", "licence": "closed", "access": "public", "date": "2023-01-04", "group_count": 2, "individual_count": 5, "intervention_count": 5, "output_count": 217, "output_calculated_count": 0, "subset_count": 10, "timecourse_count": 10, "scatter_count": 0, "reference": { "pk": 2, "study": { "sid": "4942784", "name": "Levy1971b" }, "pmid": "4942784", "sid": "4942784", "name": "Levy1971b", "doi": "10.1002/jps.2600600423", "title": "Drug biotransformation interactions in man. V. Acetaminophen and salicylic acid.", "abstract": null, "journal": "Journal of pharmaceutical sciences", "date": "1972-02-22", "authors": [ { "pk": 6, "first_name": "G", "last_name": "Levy" }, { "pk": 7, "first_name": "C G", "last_name": "Regårdh" } ] }, "reference_date": "1972-02-22", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.5, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 1.0, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "salicylic-acid", "name": "salicylic acid", "label": "salicylic acid" }, { "sid": "1-salicylate-glucuronide", "name": "1-salicylate glucuronide", "label": "1-salicylate glucuronide" }, { "sid": "salicyluric-acid", "name": "salicyluric acid", "label": "salicyluric acid" } ], "groupset": { "descriptions": [], "comments": [], "groups": [ 5, 6 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 14, 15, 16, 17, 18 ] }, "interventionset": { "descriptions": [], "comments": [ { "pk": 4, "username": "jbrandhorst", "text": "They received oral doses of 1 g. acetaminophen in one test, 1g acetaminophen and salicylic acid (1 g 2 hr. before and 0.5 g. 4 hr. after acetaminophen) in the second test, and a total of 1.5 g. salicylic acid (1 g. initially and 0.5 g. 6 hr. later) in the third test. The drugs were given in aqueous solution (salicylic acid as sodium salicylate) in the morning On an empty stomach. Food was withheld for at least 2hr. " } ], "interventions": [ 4, 6, 8, 10, 12 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 397, 398, 399, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 430, 431, 432, 433, 434, 435, 436, 445, 446, 447, 448, 449, 450, 451, 452, 501, 502, 503, 504, 505, 506, 507, 508, 509, 510, 511, 512, 513, 514, 515, 516, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 575, 576, 577, 578, 579, 580, 629, 630, 631, 632, 633, 634, 635, 636, 637, 638, 639, 640, 641, 642, 643, 644, 718, 719, 720, 721, 735, 736, 737, 738, 739, 740, 741, 742, 743, 744, 745, 746, 747, 748, 749, 750, 751, 485, 486, 487, 488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499, 500, 549, 550, 551, 772, 773, 774, 775, 776, 777, 778, 779, 780, 781, 782, 783, 552, 553, 554, 555, 556, 557, 558, 559, 560, 561, 562, 563, 564, 613, 614, 615, 616, 617, 618, 619, 620, 621, 622, 623, 624, 625, 626, 627, 628, 755, 756, 757, 758, 759, 760, 761, 762, 763, 764, 765, 766, 767, 768, 769, 770, 771, 722, 723, 724, 725, 726, 727, 728, 729, 730, 731, 732, 733, 734, 784, 785, 786, 787, 788, 789, 790, 752, 753, 754 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ] } }, { "pk": "3", "sid": "PKDB00167", "name": "Sanaka2002", "licence": "closed", "access": "public", "date": "2019-09-11", "group_count": 1, "individual_count": 20, "intervention_count": 2, "output_count": 118, "output_calculated_count": 36, "subset_count": 4, "timecourse_count": 4, "scatter_count": 0, "reference": { "pk": 3, "study": { "sid": "PKDB00167", "name": "Sanaka2002" }, "pmid": null, "sid": "Sanaka2002", "name": "Sanaka2002", "doi": null, "title": "Gastric emptying of liquids is delayed by co-ingesting solids: a study using salivary paracetamol concentrations", "abstract": null, "journal": "Gastroenterology", "date": "2002-10-10", "authors": [ { "pk": 8, "first_name": "Masaki", "last_name": "Sanaka" }, { "pk": 9, "first_name": "Satoru", "last_name": "Mineshita" } ] }, "reference_date": "2002-10-10", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 3.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 1.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [ { "pk": 2, "text": "Five healthy male volunteers (32–64 years of age) were studied after informed consent was obtained. None of them had currently taken medications, or had undergone abdominal surgery." }, { "pk": 3, "text": "Following overnight fast." } ], "comments": [], "groups": [ 7 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38 ] }, "interventionset": { "descriptions": [ { "pk": 4, "text": "Following an overnight fast, they received 10mg/kg paracetamol in 200 ml water alone on one occasion, and received this solution after consuming a 400 kcal-containing cookie on another occasion." }, { "pk": 5, "text": "Paracetamol absorption was studied on two occasions, spaced at least 3 days apart. Subjects were allocated to each occasion in random order. Following an overnight fast, they received 10mg/kg paracetamol dissolved in 200ml water alone (control study), and on another occasion, they received the solution just after consuming a commercial energy-concentrated cookie containing 400kcal (Calorie mate; Ohtsuka, Tokyo, Japan; 4.1g protein, 11.1g fat, and 21.0g carbohydrate per 200kcal) (food study). Promptly after paracetamol ingestion, the mouth was thoroughly rinsed with 600 ml water (200ml x 3)." } ], "comments": [ { "pk": 5, "username": "jbrandhorst", "text": "The sitting position was maintained for the initial 1.0 h. Food, fluid, and tobacco were withheld during the first 2.0 h." } ], "interventions": [ 14, 16 ] }, "outputset": { "descriptions": [ { "pk": 6, "text": "After thorough rinsing of the month, 1 ml saliva was obtained, simultaneously with 2 ml blood, at 0, 0.25, 0.5, 0.75, 1.0, 2.0, 3.0, 4.0, and 6.0 h after paracetamol intake." } ], "comments": [], "outputs": [ 835, 836, 837, 838, 839, 840, 841, 842, 843, 844, 845, 846, 847, 848, 849, 850, 801, 802, 803, 804, 805, 806, 807, 808, 809, 810, 831, 832, 833, 834, 871, 872, 873, 874, 875, 876, 877, 878, 879, 880, 881, 882, 883, 884, 885, 886, 887, 888, 889, 890, 923, 924, 925, 926, 927, 928, 929, 930, 964, 965, 966, 967, 968, 969, 970, 971, 972, 931, 939, 940, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 951, 952, 953, 954, 932, 933, 934, 935, 936, 937, 938, 982, 983, 984, 985, 986, 987, 988, 989, 990, 1000, 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1018, 1019, 1020, 1021, 1022, 1023, 1024, 1025, 1026 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 20, 21, 22, 23 ] } }, { "pk": "4", "sid": "PKDB00155", "name": "Forrest1979", "licence": "closed", "access": "public", "date": "2019-07-28", "group_count": 5, "individual_count": 15, "intervention_count": 1, "output_count": 162, "output_calculated_count": 78, "subset_count": 12, "timecourse_count": 12, "scatter_count": 0, "reference": { "pk": 4, "study": { "sid": "PKDB00155", "name": "Forrest1979" }, "pmid": "499292", "sid": "499292", "name": "Forrest1979", "doi": null, "title": "Paracetamol metabolism in chronic liver disease.", "abstract": "The plasma concentrations and urinary excretion of paracetamol and its glucuronide, sulphate, cysteine and mercapturic acid conjugates were measured in eight normal subjects, eight patients with mild liver disease and seven patients with severe liver disease following an oral dose of 1.5 g of paracetamol. The mean plasma paracetamol half-life was similar in normal subjects (2.43 h +/- 0.19) but was significantly prolonged in all patients with severe liver disease (4.25 h +/- 1.15:p = less than 0.001). Prolongation of the paracetamol half-life was related to reduced plasma albumin and increased prothrombin time. The mean ratios of plasma concentrations of unchanged paracetamol to paracetamol glucoronide and sulphate were significantly greater in patients with sever liver disease than the normal subjects. There were no significant differences in the overall 24-h urinary excretion of paracetamol and its glucuronide, sulphate, cysteine and mercapturic acid conjugates in the three groups. The glutathione conjugation of paracetamol did not seem to be impaired in patients with severe liver disease as evidence by the production of normal amounts of the cysteine and mercapturic acid conjugates. There is thus no evidence that they are at increased risk of hepatotoxicity when given a single therapeutic dose of paracetamol.", "journal": "European journal of clinical pharmacology", "date": "1980-01-24", "authors": [ { "pk": 10, "first_name": "J A", "last_name": "Forrest" }, { "pk": 11, "first_name": "P", "last_name": "Adriaenssens" }, { "pk": 12, "first_name": "N D", "last_name": "Finlayson" }, { "pk": 13, "first_name": "L F", "last_name": "Prescott" } ] }, "reference_date": "1980-01-24", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 3.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 3.2, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "apapcys", "name": "paracetamol cysteine", "label": "paracetamol cysteine" }, { "sid": "apapmer", "name": "paracetamol mercapturate", "label": "paracetamol mercapturate" } ], "groupset": { "descriptions": [ { "pk": 7, "text": "15 patients with chronic liver disease were studied with informed consent. Their weights ranged from 45 to 77 kg (mean 61.8 kg)" }, { "pk": 8, "text": "All patients were in hospital and stable in their optimal clinical state." }, { "pk": 9, "text": "Control studies were carried out in 8 healthy male staff volunteers aged 21-34 years with weights ranging from 62 to 75 kg." }, { "pk": 10, "text": "The patients were divided into two groups, thwith with mild liver disease (Patiens 1-8) in whom serum albumin and/or the PTR were normal, and those with severe liver disease (9-15) in whom both were abnormal with exception of the patient with a lieno-renal shunt." }, { "pk": 11, "text": "Eight normal subjects, eight patients with mild liver disease and seven patients with liver disease. All patients were in hospital and stable in their optimal clinical state. None was in cardiac failure whilst only one patient (Patient 8) had a marginally raised plasma urea. Patients 11 and 13 had ascites and patients 1, 4, 10, 12 and 14 oesophageal varices. Patient 9 had previously undergone a lieno-renal shunt; this being patent as judged by the absence of varices." } ], "comments": [ { "pk": 7, "username": "jbrandhorst", "text": "A complete drug history was taken and whenever possible all drugs were stopped before paracetamol was given. Seven patients had previously been taking drugs regularly: patient 5 prednisolone; patient 7 phenobarbitone; patient 10 frusemide and spironolactone; patient 11 spironolactone and protriptyline; patient 12 bendrofluazide; patient 13 spironolactone and patient 14 bendrofluazide and spironolactone." } ], "groups": [ 8, 9, 10, 11, 12 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53 ] }, "interventionset": { "descriptions": [ { "pk": 12, "text": "After an overnight fast 1.5g of paracetamol (Panadol) was given with 40 ml of water after which food and fluids were withheld for 2 h. Venous blood samples were taken at 0, 3, 5, 7 and 9 h after the dose and urine was collected for 24 h." } ], "comments": [], "interventions": [ 18 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 1030, 1031, 1032, 1048, 1049, 1050, 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094, 1095, 1096, 1097, 1098, 1155, 1156, 1157, 1167, 1168, 1169, 1170, 1159, 1160, 1161, 1162, 1151, 1152, 1153, 1154, 1143, 1144, 1145, 1146, 1147, 1148, 1149, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1163, 1164, 1165, 1166, 1204, 1205, 1206, 1207, 1208, 1209, 1210, 1211, 1212, 1158, 1219, 1220, 1221, 1222, 1223, 1224, 1187, 1188, 1189, 1190, 1228, 1229, 1230, 1237, 1238, 1239, 1240, 1241, 1242, 1191, 1192, 1193, 1194, 1246, 1247, 1248, 1255, 1256, 1257, 1258, 1259, 1260, 1270, 1271, 1272, 1273, 1274, 1275, 1276, 1277, 1278, 1285, 1286, 1287, 1288, 1289, 1290, 1150, 1297, 1298, 1299, 1300, 1301, 1302, 1309, 1310, 1311, 1312, 1313, 1314, 1183, 1184, 1185, 1186, 1324, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35 ] } }, { "pk": "5", "sid": "PKDB00218", "name": "Lee1981", "licence": "closed", "access": "public", "date": "2019-10-25", "group_count": 3, "individual_count": 13, "intervention_count": 1, "output_count": 64, "output_calculated_count": 0, "subset_count": 0, "timecourse_count": 0, "scatter_count": 0, "reference": { "pk": 5, "study": { "sid": "PKDB00218", "name": "Lee1981" }, "pmid": "7263926", "sid": "7263926", "name": "Lee1981", "doi": null, "title": "The effect of obesity on acetaminophen pharmacokinetics in man.", "abstract": "This study examined the absorption and disposition of orally administered acetaminophen in morbidly obese patients as compared to subjects of normal weight, and possible changes in disposition as the patients underwent weight reduction through dietary modification. The overall disposition of acetaminophen was not affected by a weight loss of 8 to 30 kg; elimination half-life, time to reach the peak, and peak plasma concentration varied within each subject but not in a systematic way. The half-life was the same in the obese patients (2.6 +/- 0.85 hours) and normal subjects (2.6 +/- 0.12 hours). However, maximum plasma concentrations were reached at a significantly later time and were significantly lower in the obese patients as compared to the normals, implying an apparently lower absorption rate. The area under the plasma concentration-time curve for the obese patients when normalized to ideal body weight was more consistent with that in the normal subjects than when normalized to total body weight. Administration of a normal dose of acetaminophen to an obese patient should yield plasma levels in the same range as persons of normal weight. As total weight may exceed 200 per cent of the ideal weight in this patient group, dosing according to total rather than ideal weight could lead to toxic or lethal effects when using the 10 mg/kg dosing recommendation.", "journal": "Journal of clinical pharmacology", "date": "1981-10-25", "authors": [ { "pk": 14, "first_name": "W H", "last_name": "Lee" }, { "pk": 15, "first_name": "W G", "last_name": "Kramer" }, { "pk": 16, "first_name": "G E", "last_name": "Granville" } ] }, "reference_date": "1981-10-25", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 3.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [], "descriptions": [ { "pk": 13, "text": "The population of morbidly obese individuals consisted of four male patients hospitalized on the Endocrinology Ward of the Veterans Administration Medical Center, Houston, Tex., for the purpose of weight reduction through dietary modification. Each patient was maintained on a diet of less than 1200 calories per day and a constant number of calories and percentage of carbohydrates, protein, and fat for at least three days. None of the patients studied was in any phase of acute or rapid weight loss." }, { "pk": 14, "text": "The control subjects were three volunteer males of normal body weight." }, { "pk": 15, "text": "All patients and subjects gave signed informed consent and had no evidence of hepatic or renal disorder." } ], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [], "comments": [], "groups": [ 13, 14, 15 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66 ] }, "interventionset": { "descriptions": [ { "pk": 16, "text": "For either group, acetaminophen was administered orally as two 325-mg tablets (Philips Roxane brand of acetaminophen) with 8 oz. of water after an overnight (8-hour) fast." } ], "comments": [], "interventions": [ 20 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 1391, 1392, 1393, 1394, 1395, 1396, 1397, 1398, 1399, 1400, 1401, 1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1423, 1424, 1425, 1426, 1427, 1428, 1429, 1430, 1439, 1440, 1441, 1442, 1443, 1444, 1445, 1446, 1463, 1464, 1465, 1466, 1467, 1468, 1469, 1470, 1471, 1472, 1473, 1474, 1475, 1476, 1477, 1478 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [] } }, { "pk": "7", "sid": "PKDB00224", "name": "Prescott1993", "licence": "closed", "access": "public", "date": "2019-10-27", "group_count": 3, "individual_count": 0, "intervention_count": 2, "output_count": 84, "output_calculated_count": 27, "subset_count": 3, "timecourse_count": 3, "scatter_count": 0, "reference": { "pk": 7, "study": { "sid": "PKDB00224", "name": "Prescott1993" }, "pmid": "9114910", "sid": "9114910", "name": "Prescott1993", "doi": null, "title": "Impaired absorption of paracetamol in vegetarians.", "abstract": "1. The absorption and disposition of paracetamol was investigated in 10 healthy male Thai vegetarians and 10 similar non-vegetarians following an oral dose of 20 mg kg-1. 2. The absorption rate of paracetamol was significantly impaired in the vegetarians compared with the non-vegetarians as shown by a lower mean Cmax (11.7 +/- 1.4 vs 15.6 +/- 1.6 mg l-1; 95% confidence interval of the difference 2.49 to 5.36), increased tmax (median 1.75, range 0.75 to 3 h compared with 0.75 and 0.25 to 2 h) and an increase in the time for input of 50% of the total amount absorbed (0.54 +/- 0.38 compared with 0.20 +/- 0.10 h; 95% confidence interval of the difference 0.063 to 0.61). 3. A significantly lower total 24 h urinary recovery of paracetamol and metabolites (72.1 +/- 5.4 vs 86.4 +/- 5.4% of the dose; 95% confidence interval of the difference 8.0 to 20.6) indicated a decrease in the extent of absorption in the vegetarians also, although the total AUC values did not differ significantly between the two groups. 4. The plasma paracetamol half-life, partial metabolic clearances and fractional urinary excretion of the glucuronide, sulphate, cysteine and mercapturic acid conjugates of paracetamol were similar in the vegetarians and non-vegetarians.", "journal": "British journal of clinical pharmacology", "date": "1997-05-01", "authors": [ { "pk": 23, "first_name": "L F", "last_name": "Prescott" }, { "pk": 24, "first_name": "K", "last_name": "Yoovathaworn" }, { "pk": 25, "first_name": "K", "last_name": "Makarananda" }, { "pk": 26, "first_name": "R", "last_name": "Saivises" }, { "pk": 27, "first_name": "K", "last_name": "Sriwatanakul" } ] }, "reference_date": "1997-05-01", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 2.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "apapcys", "name": "paracetamol cysteine", "label": "paracetamol cysteine" }, { "sid": "apapgsh", "name": "paracetamol glutathione", "label": "paracetamol glutathione" }, { "sid": "apapmer", "name": "paracetamol mercapturate", "label": "paracetamol mercapturate" }, { "sid": "caf", "name": "caffeine", "label": "caffeine (137X)" } ], "groupset": { "descriptions": [ { "pk": 21, "text": "Studies were carried out in 10 healthy male Thai volunteers taking a normal diet and 10 similar subjects who had been taking a vegetarian diet for a mean of 18 (range 3 to 72) months. The mean ages and body weights of the two groups were similar at 20.2 ±0.4 and 24.1 ±5.8 years and 57.1 ±5.3 and 52.5 ±5.1 kg, respectively." } ], "comments": [ { "pk": 11, "username": "jbrandhorst", "text": "The non-vegetarians were senior medical students in Bangkok and they took a balanced diet which was typical for central Thailand. They usually had three meals a day and their diet included rice, noodles and vegetables with meat such as chicken, pork or fish daily. The food was not highly spiced and did not contain significant amounts of chilli. The vegetarians were recruited from a local community with strict dietary habits and they did not eat dairy products or eggs. The vegetarians consumed less protein and calories, and more fibre than the non-vegetarians. They usually had only one meal a day, and this contained rice, beancurd, beans, peas, peanuts and green vegetables seasoned with sesame. They drank water, fruit juice or soy-bean milk." } ], "groups": [ 20, 21, 22 ] }, "individualset": null, "interventionset": { "descriptions": [ { "pk": 22, "text": "Following an overnight fast, 20 mg kg-1 of paracetamol (Sterling Winthrop) was taken dissolved in 400 ml of 'Coca Cola'. Fluid was withheld for the next 2 h, during which time the volunteers remained seated, and no food was allowed for 4 h after dosing." } ], "comments": [ { "pk": 13, "username": "jbrandhorst", "text": "Fluid was withheld for the next 2 h, during which time the volunteers remained seated, and no food was allowed for 4 h after dosing." } ], "interventions": [ 24, 26 ] }, "outputset": { "descriptions": [], "comments": [ { "pk": 14, "username": "jbrandhorst", "text": "Attention: maunally averaged vegetarians and non-vegetarians to all group, even though there are significant differences" } ], "outputs": [ 1497, 1498, 1499, 1500, 1501, 1502, 1503, 1504, 1505, 1506, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1580, 1581, 1582, 1583, 1584, 1585, 1586, 1587, 1588, 1589, 1590, 1591, 1592, 1567, 1568, 1569, 1570, 1571, 1572, 1573, 1574, 1575, 1576, 1577, 1578, 1554, 1555, 1556, 1557, 1558, 1559, 1560, 1561, 1562, 1563, 1564, 1565, 1566, 1602, 1603, 1604, 1605, 1606, 1607, 1608, 1609, 1610, 1620, 1621, 1622, 1623, 1624, 1625, 1626, 1627, 1628, 1579, 1638, 1639, 1640, 1641, 1642, 1643, 1644, 1645, 1646 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 36, 37, 38 ] } }, { "pk": "8", "sid": "PKDB00197", "name": "Abernethy1982a", "licence": "closed", "access": "public", "date": "2019-10-01", "group_count": 3, "individual_count": 34, "intervention_count": 1, "output_count": 75, "output_calculated_count": 11, "subset_count": 2, "timecourse_count": 2, "scatter_count": 0, "reference": { "pk": 8, "study": { "sid": "PKDB00197", "name": "Abernethy1982a" }, "pmid": "6897933", "sid": "6897933", "name": "Abernethy1982a", "doi": null, "title": "Increased metabolic clearance of acetaminophen with oral contraceptive use.", "abstract": "The effect of chronic low-dose oral contraceptive steroid use on the pharmacokinetics of intravenous acetaminophen was determined. Eight women using low-dose (under 50 micrograms) estrogen oral contraceptive steroid for more than 3 months were matched for age and weight (mean age, 25.9 years; mean weight, 58.3 kg) with 8 female controls not using the steroid (mean age, 26.0 years; mean weight, 55.5 kg). No subject was taking other drugs. Oral contraceptive steroid subjects had a lower elimination half-life of acetaminophen (2.12 hours) than controls (2.71 hours) (P less than .005). Volume of distribution was similar for both groups (oral contraceptive group, 1.04 liters/kg; controls, 0.96 liters/kg; NS). Total metabolic clearance was significantly higher in oral contraceptive subjects (5.81 ml/min/kg, versus 4.12 ml/min/kg for controls; P less than .02). As volume of distribution and body weight are similar for both groups, the decrease in acetaminophen elimination half-life among contraceptive steroid users is the result of increased total metabolic clearance. Thus, low-dose estrogen oral contraceptive steroid may stimulate the metabolism of a conjugatively metabolized drug such as acetaminophen, in contrast to contraceptive steroid impairment of the clearance of some oxidatively metabolized drugs, with antipyrine being the prototype.", "journal": "Obstetrics and gynecology", "date": "1982-12-03", "authors": [ { "pk": 28, "first_name": "D R", "last_name": "Abernethy" }, { "pk": 29, "first_name": "M", "last_name": "Divoll" }, { "pk": 30, "first_name": "H R", "last_name": "Ochs" }, { "pk": 31, "first_name": "B", "last_name": "Ameer" }, { "pk": 32, "first_name": "D J", "last_name": "Greenblatt" } ] }, "reference_date": "1982-12-03", "creator": { "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, "curators": [ { "rating": 3.9, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [ { "pk": 23, "text": "8 women using low-dose (under 50 µg) estrogen oral contraceptive steroid for more than 3 months were matched for age and weight (mean age, 25.9 years; mean weight, 58.3 kg) with 8 female controls not using the steroid (mean age, 26.0 years, mean weight 55.5 kg)." }, { "pk": 24, "text": "No subject was taking other drugs, 1 was a cigarette smoker and 1 was black. All other subjects were nonsmoking white women." }, { "pk": 25, "text": "age and weight in Tab1" } ], "comments": [], "groups": [ 23, 24, 25 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124 ] }, "interventionset": { "descriptions": [ { "pk": 26, "text": "Acetaminophen was prepared in a sterile 50 mg/ml solution. Thirteen ml, containing 650 mg acetaminophen was diluted to 50ml in normal saline and administred by constant intravenous infusion over 5 minutes." } ], "comments": [], "interventions": [ 28 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 1653, 1654, 1655, 1656, 1657, 1658, 1691, 1692, 1693, 1694, 1695, 1696, 1697, 1698, 1699, 1700, 1701, 1702, 1703, 1704, 1705, 1706, 1707, 1708, 1709, 1710, 1711, 1712, 1713, 1714, 1715, 1716, 1717, 1718, 1719, 1720, 1721, 1722, 1749, 1750, 1751, 1752, 1753, 1754, 1755, 1756, 1757, 1758, 1759, 1760, 1781, 1782, 1783, 1784, 1785, 1786, 1761, 1762, 1763, 1764, 1765, 1766, 1767, 1768, 1769, 1770, 1771, 1772, 1773, 1774, 1792, 1793, 1794, 1795, 1796 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 39, 40 ] } }, { "pk": "11", "sid": "PKDB00200", "name": "Prescott1968", "licence": "closed", "access": "public", "date": "2019-10-01", "group_count": 3, "individual_count": 8, "intervention_count": 3, "output_count": 198, "output_calculated_count": 54, "subset_count": 18, "timecourse_count": 18, "scatter_count": 0, "reference": { "pk": 11, "study": { "sid": "PKDB00200", "name": "Prescott1968" }, "pmid": null, "sid": "Prescott1968", "name": "Prescott1968", "doi": null, "title": "The comparative metabolism of phenacetin and N-acetyl-p-aminophenol in man, with particular reference to effects on the kidney", "abstract": null, "journal": "Clinical Pharmacology and Therapeutics", "date": "1968-10-10", "authors": [ { "pk": 40, "first_name": "L.F.", "last_name": "Prescott" }, { "pk": 41, "first_name": "M.", "last_name": "Sansur" }, { "pk": 42, "first_name": "W.", "last_name": "Levin" }, { "pk": 43, "first_name": "A.H.", "last_name": "Conney" } ] }, "reference_date": "1968-10-10", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 3.1, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [ { "pk": 16, "username": "mkoenig", "text": "only paracetamol data digitized, phenacetin data not used" } ], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "apapcys", "name": "paracetamol cysteine", "label": "paracetamol cysteine" }, { "sid": "apapgsh", "name": "paracetamol glutathione", "label": "paracetamol glutathione" }, { "sid": "apapmer", "name": "paracetamol mercapturate", "label": "paracetamol mercapturate" } ], "groupset": { "descriptions": [ { "pk": 28, "text": "17 healthy adult volunteers during 5 day control and treatment periods as described previously [17]. Nine volunteers received phenacetin and 8 received APAP; none had taken any drugs during the preceding 6 weeks." } ], "comments": [], "groups": [ 26, 27, 28 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 125, 126, 127, 128, 129, 130, 131, 132 ] }, "interventionset": { "descriptions": [ { "pk": 29, "text": "On the first treatment day the fasting volunteers took 900 mg. of phenacetin or APAP in gelatine capsules at 8:30 A.M. (zero time), followed by a further 900 mg at 9:00 A.M." } ], "comments": [], "interventions": [ 31, 32, 34 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 1829, 1830, 1831, 1832, 1833, 1834, 1835, 1836, 1837, 1838, 1839, 1840, 1841, 1842, 1843, 1844, 1845, 1846, 1847, 1848, 1849, 1850, 1851, 1852, 1853, 1854, 1855, 1856, 1857, 1858, 1859, 1860, 1865, 1866, 1867, 1868, 2125, 2126, 1971, 1972, 1973, 1974, 1975, 1977, 1978, 1979, 1980, 1981, 2190, 2191, 2192, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2013, 2014, 2015, 2016, 2017, 2018, 1995, 1996, 1997, 1998, 1999, 2000, 1983, 1984, 1985, 1986, 1987, 1988, 2031, 2032, 1982, 1989, 1990, 1991, 1992, 1993, 2025, 2026, 2027, 2028, 2029, 2030, 2043, 2044, 2045, 2046, 2047, 2048, 2037, 2038, 2039, 2040, 2041, 2042, 2079, 2033, 2034, 2035, 2036, 2073, 2074, 2075, 2076, 2049, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2088, 2089, 2090, 2094, 2095, 2096, 2019, 2020, 2021, 2022, 2023, 2024, 2100, 2101, 2102, 2106, 2107, 2108, 1965, 1966, 1967, 1968, 1969, 1970, 2112, 2113, 2114, 2012, 2118, 2119, 2120, 2124, 1976, 2130, 2131, 2132, 2136, 2137, 2138, 2142, 2143, 2144, 2080, 2081, 2082, 2083, 2084, 2148, 2149, 2150, 2154, 2155, 2156, 2160, 2161, 2162, 2077, 2078, 2166, 2167, 2168, 2172, 2173, 2174, 2178, 2179, 2180, 1994, 2184, 2185, 2186 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58 ] } }, { "pk": "12", "sid": "PKDB00152", "name": "SevillaTirado2003", "licence": "closed", "access": "public", "date": "2019-07-28", "group_count": 1, "individual_count": 0, "intervention_count": 5, "output_count": 160, "output_calculated_count": 45, "subset_count": 5, "timecourse_count": 5, "scatter_count": 0, "reference": { "pk": 12, "study": { "sid": "PKDB00152", "name": "SevillaTirado2003" }, "pmid": "14571283", "sid": "14571283", "name": "Sevilla-Triado2003", "doi": null, "title": "Bioavailability of two new formulations of paracetamol, compared with three marketed formulations, in healthy volunteers.", "abstract": "The aim of this study was to compare the main pharmacokinetic characteristics of two new paracetamol formulations, powder sachet and tablet, with that of three commercially available paracetamol formulations: two conventional solid tablets and one effervescent tablet. Twelve healthy volunteers participated in an open, single dose (paracetamol 1,000 mg), randomized, five-way, crossover study. Formulations studied included: formulation A: 2 x 500 mg paracetamol tablets (Laboratorios Belmac S.A.); formulation B: 1 x 1,000 mg paracetamol powder sachets (Laboratorios Belmac, S.A.); formulation C: 2 x 500 mg paracetamol film-coated tablets (Panadol, SmithKline Beecham); formulation D: 2 x 500 mg paracetamol tablets (Tylenol, McNeil); and formulation E: 1 x 1,000 mg effervescent paracetamol tablets (Efferalgan, UPSA). The primary variables were area under the plasma concentration time curve extrapolated to infinity (AUC(0-infinity)), maximum plasma concentration (Cmax), and time to maximum plasma concentration (tmax). Mean AUC(0-infinity) ranged from 52.6 (B) to 56.3 microg x h/ml (D); mean Cmax varied between 17.98 (C) and 20.73 microg/ml (E); mean tmax ranged from 0.40 (E) to 0.88 h (C); and median t(1/2) varied between 2.65 (C) and 2.81 h (A). Formulations A, B and E showed significantly shorter tmax than formulation C. The tmax and Cmax values found for formulations A and B were very similar to that found for E, an effervescent tablet formulation. In conclusion, the two new formulations of paracetamol tested in this study were absorbed rapidly after a single oral dose in healthy volunteers, similar to an effervescent paracetamol formulation and significantly faster than two ordinary commercialized paracetamol tablets.", "journal": "Methods and findings in experimental and clinical pharmacology", "date": "2004-03-09", "authors": [ { "pk": 44, "first_name": "F J", "last_name": "Sevilla-Tirado" }, { "pk": 45, "first_name": "E B", "last_name": "González-Vallejo" }, { "pk": 46, "first_name": "A C", "last_name": "Leary" }, { "pk": 47, "first_name": "H J", "last_name": "Breedt" }, { "pk": 48, "first_name": "V J", "last_name": "Hyde" }, { "pk": 49, "first_name": "N", "last_name": "Fernández-Hernando" } ] }, "reference_date": "2004-03-09", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 3.2, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [ { "pk": 30, "text": "Bioavailability of Two New Formulations of Paracetamol, Compared With Three Marketed Formulations, in Healthy Volunteers" } ], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [ { "pk": 31, "text": "Paracetamol was permitted up to 72 h prior to the trial, but could not be used as concomitant medication." }, { "pk": 32, "text": "Twelve healthy volunteers were included: 8 males and 4 females aged 29 ± 9.7 years. Concomitant medication was not permitted for 14 days prior to or during the trial. Paracetamol was permitted up to 72 h prior to the trial, but could not be used as concomitant medication." } ], "comments": [], "groups": [ 29 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [] }, "interventionset": { "descriptions": [ { "pk": 33, "text": "A: 2 x 500 mg paracetamol tablets (Laboratorios Belmac S.A)" }, { "pk": 34, "text": "B: 1 x 1000 mg paracetamol powder sachets (Laboratorios Belmac, S.A.)" }, { "pk": 35, "text": "C: 2 x 500 mg paracetamol film-coated tablets (Panadol®, SmithKline Beecham)" }, { "pk": 36, "text": "D: 2 x 500 mg paracetamol tablets (Tylenol®, McNeil)" }, { "pk": 37, "text": "E: 1 x 1000 mg effervescent paracetamol tablets (Efferalgan®, UPSA)." } ], "comments": [ { "pk": 17, "username": "jbrandhorst", "text": "The five formulations were given to each volunteer in random order, separated by a washout period of at least 3 days." } ], "interventions": [ 36, 38, 40, 42, 44 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 2213, 2214, 2215, 2216, 2217, 2218, 2219, 2220, 2221, 2222, 2223, 2224, 2225, 2226, 2227, 2228, 2229, 2230, 2231, 2232, 2238, 2239, 2240, 2241, 2242, 2263, 2264, 2265, 2266, 2267, 2268, 2269, 2270, 2271, 2272, 2273, 2274, 2275, 2276, 2277, 2278, 2279, 2280, 2281, 2282, 2381, 2382, 2383, 2384, 2385, 2353, 2354, 2355, 2356, 2357, 2358, 2359, 2360, 2361, 2367, 2368, 2369, 2370, 2371, 2372, 2373, 2374, 2375, 2376, 2377, 2378, 2379, 2380, 2432, 2433, 2434, 2435, 2436, 2395, 2396, 2397, 2398, 2399, 2400, 2401, 2402, 2409, 2410, 2411, 2412, 2413, 2414, 2415, 2416, 2417, 2418, 2419, 2420, 2421, 2422, 2437, 2438, 2439, 2440, 2386, 2387, 2388, 2389, 2390, 2391, 2392, 2393, 2394, 2450, 2451, 2452, 2453, 2454, 2455, 2456, 2457, 2458, 2403, 2404, 2405, 2406, 2407, 2408, 2468, 2469, 2470, 2471, 2472, 2473, 2474, 2475, 2476, 2486, 2487, 2488, 2489, 2490, 2491, 2492, 2493, 2494, 2362, 2363, 2364, 2365, 2366, 2504, 2505, 2506, 2507, 2508, 2509, 2510, 2511, 2512 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 59, 60, 61, 62, 63 ] } }, { "pk": "13", "sid": "PKDB00122", "name": "Briant1976", "licence": "closed", "access": "public", "date": "2019-05-14", "group_count": 7, "individual_count": 57, "intervention_count": 1, "output_count": 69, "output_calculated_count": 0, "subset_count": 0, "timecourse_count": 0, "scatter_count": 0, "reference": { "pk": 13, "study": { "sid": "PKDB00122", "name": "Briant1976" }, "pmid": null, "sid": "Briant1976", "name": "Briant1976", "doi": null, "title": "The Rate of Acetaminophen Metabolism in the Elderly and the Young", "abstract": "Twenty‐eight elderly volunteers of the 65+ age group and 28 control subjects of the 20–40 age group each received a single oral dose (1 gm) of acetaminophen in powder form. The plasma level of acetaminophen was measured over 6 hours. Plasma half‐life, clearance and relative volume of distribution of the drug were calculated. Within each age group there was a wide (threefold) range of plasma half‐life and clearance rate, with a great deal of overlap between the two groups. However, for the elderly, the group mean half‐life of acetaminophen was 2.17 hours, significantly longer than for the young (1.75 hours). The clearance rate in the elderly was significantly slower than in the young (.254 and .340 L/kg/hour respectively). There was no age‐related difference in volume of distribution of the drug by any measure, and no significant influence of sex.", "journal": "Journal of the American Geriatrics Society", "date": "1976-08-01", "authors": [ { "pk": 50, "first_name": "Robin H.", "last_name": "Briant" } ] }, "reference_date": "1976-08-01", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 3.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [ { "pk": 38, "text": "Twenty‐eight elderly volunteers of the 65+ age group and 28 control subjects of the 20–40 age group each received a single oral dose (1 gm) of acetaminophen in powder form. The plasma level of acetaminophen was measured over 6 hours. Plasma half‐life, clearance and relative volume of distribution of the drug were calculated. Within each age group there was a wide (threefold) range of plasma half‐life and clearance rate, with a great deal of overlap between the two groups. However, for the elderly, the group mean half‐life of acetaminophen was 2.17 hours, significantly longer than for the young (1.75 hours). The clearance rate in the elderly was significantly slower than in the young (.254 and .340 L/kg/hour respectively). There was no age‐related difference in volume of distribution of the drug by any measure, and no significant influence of sex." }, { "pk": 39, "text": "All had normal biochemical profiles for hepatic function, serum albumin levels of more than 3.0 gm/100 ml and hemoglobin levels of more than 10.0 gm / 1OO ml. Of the 28 subjects, 17 had elevated levels of blood urea, ranging from 45 to 67 mg/100 ml (normal, 20-45mg)." } ], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [ { "pk": 40, "text": "They were allowed no drugs in the 2 weeks prior to the study, except for some women who were taking oral contraceptives." }, { "pk": 41, "text": "All subjects were white New Zealanders in good health." }, { "pk": 42, "text": "Biochemical and hematologic screening revealed no evidence of impaired liver function." } ], "comments": [ { "pk": 23, "username": "jbrandhorst", "text": "additional data point in Fig1" } ], "groups": [ 30, 31, 32, 33, 34, 35, 36 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189 ] }, "interventionset": { "descriptions": [ { "pk": 43, "text": "After an overnight fast, acetaminophen (1.0 gm as a powder) was given as a single oral dose, washed down with a little water. Blood samples were taken before, and 1, 2, 4 and 6 hours after drug administration." } ], "comments": [], "interventions": [ 46 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 2525, 2526, 2527, 2528, 2529, 2530, 2531, 2532, 2533, 2534, 2535, 2536, 2594, 2595, 2596, 2597, 2598, 2599, 2600, 2601, 2602, 2603, 2604, 2605, 2606, 2607, 2608, 2609, 2610, 2611, 2612, 2613, 2614, 2615, 2616, 2617, 2618, 2619, 2620, 2621, 2622, 2623, 2624, 2625, 2626, 2627, 2628, 2629, 2630, 2631, 2632, 2633, 2634, 2635, 2636, 2637, 2638, 2639, 2640, 2641, 2642, 2643, 2644, 2645, 2646, 2647, 2648, 2649, 2650 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [] } }, { "pk": "14", "sid": "PKDB00195", "name": "Clements1984", "licence": "open", "access": "public", "date": "2019-09-30", "group_count": 1, "individual_count": 0, "intervention_count": 5, "output_count": 98, "output_calculated_count": 24, "subset_count": 4, "timecourse_count": 4, "scatter_count": 0, "reference": { "pk": 14, "study": { "sid": "PKDB00195", "name": "Clements1984" }, "pmid": "6487489", "sid": "6487489", "name": "Clements1984", "doi": null, "title": "The role of sulphate conjugation in the metabolism and disposition of oral and intravenous paracetamol in man.", "abstract": "The effects of paracetamol dose (5 and 20 mg/kg) and route of administration (intravenous and oral) on the urinary excretion of paracetamol and its glucuronide, sulphate, cysteine and mercapturic acid conjugates were studied in five healthy subjects. The fractional urinary excretion of unchanged paracetamol and its conjugates was independent of the route of administration at both dose levels, suggesting that the gastrointestinal tract is not an important site for paracetamol metabolism. The percentage of the dose excreted as the sulphate conjugate was significantly higher after 5 than after 20 mg/kg (37.7% and 33.3% respectively) and this is consistent with saturation of sulphate conjugation. No significant effect of paracetamol dose upon the area under the plasma concentration-time curve (AUC), corrected for dose, was found for the sulphate or glucuronide conjugates. The total plasma clearance of paracetamol and the renal clearance of the sulphate conjugate were significantly higher after the 5 than the 20 mg/kg dose (331 +/- 42 ml/min and 295 +/- 48 ml/min; 273 +/- 74 ml/min and 205 +/- 46 ml/min respectively). The oral systemic availability of paracetamol was 80% and independent of dose.", "journal": "British journal of clinical pharmacology", "date": "1984-12-20", "authors": [ { "pk": 51, "first_name": "J A", "last_name": "Clements" }, { "pk": 52, "first_name": "J A", "last_name": "Critchley" }, { "pk": 53, "first_name": "L F", "last_name": "Prescott" } ] }, "reference_date": "1984-12-20", "creator": { "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, "curators": [ { "rating": 2.5, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 0.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [ { "pk": 152, "name": "data/Clements1984_Fig1.png", "file": "/media/data/Clements1984_Fig1.png" }, { "pk": 146, "name": "data/.Clements1984_Fig1.tsv", "file": "/media/data/.Clements1984_Fig1.tsv" }, { "pk": 151, "name": "data/Clements1984.pdf", "file": "/media/data/Clements1984.pdf" }, { "pk": 147, "name": "data/Clements1984_Tab1.png", "file": "/media/data/Clements1984_Tab1.png" }, { "pk": 144, "name": "data/.Clements1984_Tab1.tsv", "file": "/media/data/.Clements1984_Tab1.tsv" }, { "pk": 148, "name": "data/Clements1984_Tab2.png", "file": "/media/data/Clements1984_Tab2.png" }, { "pk": 149, "name": "data/.Clements1984_Tab2.tsv", "file": "/media/data/.Clements1984_Tab2.tsv" }, { "pk": 150, "name": "data/.Clements1984_TabA.tsv", "file": "/media/data/.Clements1984_TabA.tsv" }, { "pk": 145, "name": "data/Clements1984.xlsx", "file": "/media/data/Clements1984.xlsx" } ], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "apapmer", "name": "paracetamol mercapturate", "label": "paracetamol mercapturate" }, { "sid": "caf", "name": "caffeine", "label": "caffeine (137X)" } ], "groupset": { "descriptions": [ { "pk": 44, "text": "5 healthy subjects" }, { "pk": 45, "text": "Five healthy male subjects (age 29 to 39 years, mean 33.4 years; weight 66 to 83 kg, mean 72.4 kg) who were taking no other drugs participated in the study." } ], "comments": [], "groups": [ 37 ] }, "individualset": null, "interventionset": { "descriptions": [ { "pk": 46, "text": "Each fasted overnight and was given each dose of intravenous paracetamol (5 or 20 mg/kg) by constant infusion over 2 h using an IMED pump (IMED Corporation, California). Intravenous paracetamol (0.875 and 3.5 mg/ml) was prepared in phosphate buffer (pH 6.0) and sterilised by filtration. On subsequent occasions paracetamol was dissolved in 400 ml of 'Coca Cola' and ingested over 2 h; 50 ml aliquots were taken over successive 15 min periods." } ], "comments": [ { "pk": 24, "username": "jbrandhorst", "text": "On subsequent occasions paracetamol was dissolved in 400 ml of 'Coca Cola' and ingested over 2 h" }, { "pk": 25, "username": "jbrandhorst", "text": "The subjectsremained seated for 2 h and then resumednormal activities. Food, drink and tobacco wereallowed after 4 h. " }, { "pk": 26, "username": "jbrandhorst", "text": "Each of the four studies was separated by at least one week." } ], "interventions": [ 48, 50, 52, 54, 56 ] }, "outputset": { "descriptions": [], "comments": [ { "pk": 28, "username": "jbrandhorst", "text": "Tab2: Tabulated values of AUC for the 20 mg/kg dose are the observed values divided by 4.0) (mean ± s.d.)" } ], "outputs": [ 2667, 2668, 2669, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2680, 2681, 2682, 2695, 2696, 2697, 2698, 2699, 2700, 2701, 2702, 2703, 2704, 2705, 2706, 2713, 2714, 2715, 2716, 2717, 2718, 2789, 2790, 2791, 2792, 2793, 2794, 2795, 2796, 2797, 2798, 2805, 2806, 2807, 2808, 2809, 2810, 2769, 2770, 2771, 2772, 2773, 2774, 2779, 2780, 2781, 2782, 2783, 2784, 2785, 2786, 2787, 2788, 2768, 2775, 2776, 2777, 2778, 2817, 2818, 2819, 2820, 2821, 2822, 2829, 2830, 2831, 2832, 2833, 2834, 2759, 2760, 2761, 2762, 2763, 2764, 2765, 2766, 2767, 2841, 2842, 2843, 2844, 2845, 2846 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 64, 65, 66, 67 ] } }, { "pk": "15", "sid": "PKDB00262", "name": "Brodie1980", "licence": "closed", "access": "public", "date": "2019-11-08", "group_count": 5, "individual_count": 0, "intervention_count": 3, "output_count": 12, "output_calculated_count": 0, "subset_count": 0, "timecourse_count": 0, "scatter_count": 0, "reference": { "pk": 15, "study": { "sid": "PKDB00262", "name": "Brodie1980" }, "pmid": "7397068", "sid": "7397068", "name": "Brodie1980", "doi": "10.1111/j.1365-2125.1980.tb05853.x", "title": "Drug metabolism in white vegetarians.", "abstract": null, "journal": "British journal of clinical pharmacology", "date": "1980-10-21", "authors": [ { "pk": 54, "first_name": "M J", "last_name": "Brodie" }, { "pk": 55, "first_name": "A R", "last_name": "Boobis" }, { "pk": 56, "first_name": "E L", "last_name": "Toverud" }, { "pk": 57, "first_name": "W", "last_name": "Ellis" }, { "pk": 58, "first_name": "S", "last_name": "Murray" }, { "pk": 59, "first_name": "C T", "last_name": "Dollery" }, { "pk": 60, "first_name": "S", "last_name": "Webster" }, { "pk": 61, "first_name": "R", "last_name": "Harrison" } ] }, "reference_date": "1980-10-21", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.5, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 2.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "phenacetin", "name": "phenacetin", "label": "phenacetin" }, { "sid": "antipyrine", "name": "antipyrine", "label": "antipyrine" } ], "groupset": { "descriptions": [], "comments": [ { "pk": 29, "username": "jbrandhorst", "text": "very strange group setup, in part published elsewhere (Dollory1979)" }, { "pk": 30, "username": "jbrandhorst", "text": "Seven were lactovegetarians and two were vegans. They had been vegetarians for a mean of 5.1 years (0.5-14 years)." } ], "groups": [ 38, 39, 40, 41, 42 ] }, "individualset": null, "interventionset": { "descriptions": [ { "pk": 48, "text": "The volunteers were studied on two occasions. On the first, antipyrine 600 mg and paracetamol 1.5 g were taken together and on the second, phenacetin 900 mg was ingested, both following an overnight fast." } ], "comments": [], "interventions": [ 58, 60, 62 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 2865, 2866, 2867, 2868, 2869, 2870, 2859, 2860, 2861, 2862, 2863, 2864 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [] } }, { "pk": "16", "sid": "PKDB00133", "name": "Itoh2002", "licence": "closed", "access": "public", "date": "2019-06-20", "group_count": 1, "individual_count": 0, "intervention_count": 3, "output_count": 196, "output_calculated_count": 81, "subset_count": 11, "timecourse_count": 11, "scatter_count": 0, "reference": { "pk": 16, "study": { "sid": "PKDB00133", "name": "Itoh2002" }, "pmid": "12079004", "sid": "12079004", "name": "Itoh2002", "doi": null, "title": "Effect of nizatidine on paracetamol and its metabolites in human plasma.", "abstract": "The effect of the histamine H2-receptor antagonist, nizatidine, on plasma concentrations of paracetamol has been investigated with respectto hepatic metabolism. Paracetamol (1000 mg) together with 300 or 150 mg nizatidine or placebo was orally administered to five healthy male volunteers. Venous blood samples were taken before and after administration. Plasma paracetamol and paracetamol conjugates (glucuronide and sulfate) were measured by high-performance liquid chromatography. The pharmacokinetic parameters were calculated from the plasma paracetamol concentration-time curves of each volunteer. The plasma nizatidine concentration was highest (2420.0+/-192.4 and 996.0+/-54.6 ng mL(-1)) in the sample taken 1 h after administration of 300 mg nizatidine (high dose) and 150mg nizatidine (low dose), respectively. Plasma paracetamol concentrations with nizatidine (high and low doses) were increased significantly at 45-120 min and 45-60 min, respectively, compared with placebo. The total area under the plasma paracetamol concentration-time curve from 0 to 180 min (2361.5+/-146.4 and 2085.75+/-73.5 microg min mL(-1)) significantly increased after coadministration of nizatidine (high and low doses), respectively (P < 0.01 vs placebo). Paracetamol glucuronide concentrations with nizatidine (high and low doses) were decreased significantly at 30-45 min and 30 min, respectively, compared with placebo. However, plasma paracetamol sulfate concentrations with nizatidine (high and low doses) were not significantly altered. The coadministration of nizatidine (150 and 300 mg) dose-dependently reduces plasma paracetamol glucuronide concentrations and increases plasma paracetamol concentrations. The effects of nizatidine could result from the inhibition of glucuronyltransferase. Thus, care is necessary when paracetamol and nizatidine are coadministered.", "journal": "The Journal of pharmacy and pharmacology", "date": "2003-02-13", "authors": [ { "pk": 62, "first_name": "Hiroki", "last_name": "Itoh" }, { "pk": 63, "first_name": "Toshiaki", "last_name": "Nagano" }, { "pk": 64, "first_name": "Masaharu", "last_name": "Takeyama" } ] }, "reference_date": "2003-02-13", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 3.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [ { "pk": 49, "text": "Effect of nizatidine on paracetamol and its metabolites in human plasma." } ], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "nizatidine", "name": "nizatidine", "label": "nizatidine" } ], "groupset": { "descriptions": [ { "pk": 50, "text": "Five healthy male volunteers, aged 23-29 years (median 26 years), weighing 55-68 kg (median 62 kg), participated in the study." }, { "pk": 51, "text": "The subjects did not receive any medication one week before the study, and fasted for 12 h before the study commenced and during the experiments." } ], "comments": [], "groups": [ 43 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [] }, "interventionset": { "descriptions": [ { "pk": 52, "text": "Paracetamol (1000 mg) together with 300 or 150 mg nizatidine or placebo was orally administered to five healthy male volunteers." }, { "pk": 53, "text": "Paracetamol (Calonal tablets; Showa Yakuhin Kako Co., Ltd, Tokyo, Japan) and nizatidine (Acinon capsules ; Zeria Pharmaceutical Co., Ltd, Osaka, Japan) were used. Lactose (Merck hoei Co., Ltd, Osaka, Japan) was used as placebo. Standard paracetamol and paracetamol glucuronide were purchased from Sigma Chemical Co. (St Louis, MO). Standard paracetamol sulfate was supplied by Hokuriku Seiyaku Co., Ltd (Fukui, Japan). All other reagents were of analytical reagent grade from commercial sources." }, { "pk": 54, "text": "Paracetamol (1000 mg)together with 300 mg nizatidine, 150 mg nizatidine or placebo were administered orally with 100 mL water." } ], "comments": [ { "pk": 31, "username": "jbrandhorst", "text": "Each subject was administered these drugs at an interval of three weeks. " }, { "pk": 32, "username": "jbrandhorst", "text": "The study was carried out from 0800 to 1100 h." } ], "interventions": [ 64, 66, 68 ] }, "outputset": { "descriptions": [ { "pk": 55, "text": "Venous blood samples (10 mL) were taken from a forearm vein before and at 15, 30, 45, 60, 90, 120 and 180 min after paracetamol administration. The study was carried out from 0800 to 1100 h." } ], "comments": [ { "pk": 33, "username": "mkoenig", "text": "In Figure 4 the maximum error bars were used for all data sets. It was not possible to discriminate." } ], "outputs": [ 2898, 2899, 2900, 2901, 2902, 2903, 2904, 2905, 2906, 2907, 2908, 2909, 2910, 2911, 2912, 2913, 2914, 2915, 2916, 2917, 2918, 2919, 2920, 2921, 2922, 2923, 2924, 3230, 3029, 3030, 3031, 3032, 3033, 3034, 3037, 3038, 3039, 3040, 3041, 3042, 3043, 3044, 3021, 3022, 3023, 3024, 3025, 3026, 3027, 3028, 3013, 3014, 3015, 3016, 3017, 3018, 3019, 3020, 3085, 3077, 3078, 3079, 3080, 3081, 3082, 3083, 3084, 3069, 3070, 3071, 3072, 3073, 3074, 3075, 3076, 3093, 3094, 3095, 3096, 3097, 3098, 3099, 3061, 3062, 3063, 3064, 3065, 3066, 3067, 3231, 3232, 3242, 3243, 3244, 3045, 3046, 3047, 3048, 3049, 3050, 3051, 3052, 3110, 3111, 3112, 3113, 3114, 3115, 3116, 3117, 3118, 3086, 3087, 3088, 3089, 3090, 3091, 3092, 3125, 3126, 3127, 3128, 3129, 3130, 3137, 3138, 3139, 3140, 3141, 3142, 3149, 3150, 3151, 3152, 3153, 3154, 3245, 3246, 3035, 3036, 3164, 3165, 3166, 3167, 3168, 3169, 3170, 3171, 3172, 3100, 3179, 3180, 3181, 3182, 3183, 3184, 3194, 3195, 3196, 3197, 3198, 3199, 3200, 3201, 3202, 3212, 3213, 3214, 3215, 3216, 3217, 3218, 3219, 3220, 3068, 3227, 3228, 3229, 3247, 3248, 3249, 3250, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3060, 3257, 3258, 3259, 3260, 3261, 3262 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78 ] } }, { "pk": "17", "sid": "PKDB00183", "name": "Paintaud1998", "licence": "closed", "access": "public", "date": "2019-09-26", "group_count": 1, "individual_count": 15, "intervention_count": 3, "output_count": 536, "output_calculated_count": 270, "subset_count": 32, "timecourse_count": 32, "scatter_count": 0, "reference": { "pk": 17, "study": { "sid": "PKDB00183", "name": "Paintaud1998" }, "pmid": "9516037", "sid": "9516037", "name": "Paintaud1998", "doi": null, "title": "Intraindividual variability of paracetamol absorption kinetics after a semi-solid meal in healthy volunteers.", "abstract": "The assessment of paracetamol absorption kinetics is reproducible when the drug is given together with a semi-solid meal in Helicobacter pylori-negative healthy subjects.", "journal": "European journal of clinical pharmacology", "date": "1998-04-30", "authors": [ { "pk": 65, "first_name": "G", "last_name": "Paintaud" }, { "pk": 66, "first_name": "P", "last_name": "Thibault" }, { "pk": 67, "first_name": "P E", "last_name": "Queneau" }, { "pk": 68, "first_name": "J", "last_name": "Magnette" }, { "pk": 69, "first_name": "M", "last_name": "Bérard" }, { "pk": 70, "first_name": "L", "last_name": "Rumbach" }, { "pk": 71, "first_name": "P R", "last_name": "Bechtel" }, { "pk": 72, "first_name": "P", "last_name": "Carayon" } ] }, "reference_date": "1998-04-30", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 2.7, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [], "descriptions": [ { "pk": 56, "text": "The pharmacokinetics of paracetamol was studied on two occasions in 15 healthy volunteers without Helicobacter pylori antibodies." }, { "pk": 57, "text": "Thirty-five healthy subjects were pre-included and tested for the absence of Helicobacter pylori antibodies by means of an ELISA (Institut Pasteur, Paris): 15 (14 males and 1 female) had negative serology and therefore participated in the study." }, { "pk": 58, "text": "The mean (range) age was 37 (20–51) years, body weight 77 (60–100) kg and height 177 (168–196) cm. All were found to be healthy by routine clinical examination and laboratory tests, including measurement of blood glucose. They had no medical history, except for an appendectomy in two subjects and the surgical cure of an inguinal hernia in one subject." }, { "pk": 59, "text": "The ultra-sound examination of the abdomen was normal in all subjects except for one who had a single kidney." }, { "pk": 60, "text": "None of the subjects was a smoker and none had taken drugs for at least 1 week before the study." } ], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [], "comments": [], "groups": [ 44 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204 ] }, "interventionset": { "descriptions": [ { "pk": 61, "text": "A 1-g dose of paracetamol was given as a solution together with a standardised semi-solid meal and the subjects stayed in the supine position." }, { "pk": 62, "text": "Paracetamol pharmacokinetics was studied on two occasions separated by a 1-week interval (studies were performed on the same day of the week for each volunteer), except for subject 9, for whom the interval was 10 days. After overnight fasting, the subjects were given 1 g paracetamol (Eeralgan, eervescent tablets, UPSA, France) dissolved in 100 ml water at 0800 hours. The drug was taken together with a standardised semi-solid meal, consisting of a mixture of two doses of vanilla flavour Nutricre´ mal (Sodie´ tal, Saint-Malo, France), 10 g sunflower oil and 28 g maltose dextrin, corresponding to 18% proteins, 31% lipids and 52% carbohydrates, for a total of 504 kcal and a volume of 280 ml. Another 100-ml glass of water was given just after the meal and also 2 h later; a non-standardised lunch was served in the research unit 4 h after dosing. Since the absorption of paracetamol is altered by posture and activity [7], the subjects stayed in the supine position, on the right side, for the first 2 h and only modest activity was allowed for the next 4 h." } ], "comments": [], "interventions": [ 70, 72, 74 ] }, "outputset": { "descriptions": [], "comments": [ { "pk": 37, "username": "jbrandhorst", "text": "It is not clear what values in parentheses represent in Tab1 (clear CV_B and CV_W digitised but not uploaded)" } ], "outputs": [ 3273, 3274, 3275, 3276, 3277, 3278, 3279, 3280, 3281, 3282, 3531, 3532, 3533, 3555, 3556, 3557, 3558, 3559, 3560, 3561, 3579, 3571, 3572, 3573, 3574, 3575, 3576, 3577, 3563, 3564, 3565, 3566, 3567, 3568, 3569, 3570, 3534, 3535, 3536, 3537, 3538, 3547, 3548, 3549, 3550, 3551, 3552, 3553, 3554, 3580, 3581, 3582, 3583, 3584, 3585, 3586, 3587, 3588, 3589, 3590, 3591, 3592, 3593, 3619, 3620, 3621, 3622, 3623, 3624, 3625, 3595, 3596, 3597, 3598, 3599, 3600, 3601, 3611, 3612, 3613, 3614, 3615, 3616, 3617, 3618, 3659, 3660, 3661, 3662, 3663, 3664, 3665, 3626, 3667, 3668, 3669, 3670, 3671, 3627, 3628, 3629, 3630, 3631, 3632, 3633, 3634, 3643, 3644, 3645, 3646, 3647, 3648, 3649, 3650, 3651, 3652, 3653, 3654, 3655, 3656, 3657, 3675, 3676, 3677, 3678, 3679, 3680, 3681, 3682, 3707, 3708, 3709, 3710, 3711, 3712, 3713, 3714, 3715, 3716, 3672, 3673, 3674, 3683, 3684, 3685, 3686, 3687, 3688, 3689, 3691, 3692, 3693, 3694, 3695, 3696, 3697, 3698, 3739, 3740, 3741, 3742, 3743, 3744, 3745, 3723, 3724, 3725, 3726, 3727, 3728, 3729, 3730, 3731, 3732, 3733, 3734, 3735, 3736, 3737, 3747, 3748, 3749, 3750, 3751, 3752, 3753, 3754, 3717, 3718, 3719, 3720, 3721, 3722, 3539, 3540, 3541, 3542, 3543, 3544, 3545, 3546, 3762, 3779, 3780, 3781, 3782, 3783, 3784, 3785, 3804, 3805, 3806, 3807, 3808, 3809, 3810, 3811, 3812, 3562, 3822, 3823, 3824, 3825, 3826, 3827, 3828, 3829, 3830, 3787, 3788, 3789, 3790, 3791, 3792, 3793, 3794, 3840, 3841, 3842, 3843, 3844, 3845, 3846, 3847, 3848, 3635, 3636, 3637, 3638, 3639, 3640, 3641, 3642, 3858, 3859, 3860, 3861, 3862, 3863, 3864, 3865, 3866, 3603, 3604, 3605, 3606, 3607, 3608, 3609, 3610, 3876, 3877, 3878, 3879, 3880, 3881, 3882, 3883, 3884, 3699, 3700, 3701, 3702, 3703, 3704, 3705, 3706, 3894, 3895, 3896, 3897, 3898, 3899, 3900, 3901, 3902, 3755, 3756, 3757, 3758, 3759, 3760, 3761, 3906, 3907, 3908, 3918, 3919, 3920, 3921, 3922, 3923, 3924, 3925, 3926, 3936, 3937, 3938, 3939, 3940, 3941, 3942, 3943, 3944, 3746, 3954, 3955, 3956, 3957, 3958, 3959, 3960, 3961, 3962, 3594, 3972, 3973, 3974, 3975, 3976, 3977, 3978, 3979, 3980, 3990, 3991, 3992, 3993, 3994, 3995, 3996, 3997, 3998, 4008, 4009, 4010, 4011, 4012, 4013, 4014, 4015, 4016, 3666, 4020, 4021, 4022, 3578, 4032, 4033, 4034, 4035, 4036, 4037, 4038, 4039, 4040, 3738, 4050, 4051, 4052, 4053, 4054, 4055, 4056, 4057, 4058, 4068, 4069, 4070, 4071, 4072, 4073, 4074, 4075, 4076, 4086, 4087, 4088, 4089, 4090, 4091, 4092, 4093, 4094, 3523, 3524, 3525, 3526, 3527, 3528, 3529, 3530, 4104, 4105, 4106, 4107, 4108, 4109, 4110, 4111, 4112, 4122, 4123, 4124, 4125, 4126, 4127, 4128, 4129, 4130, 3602, 4140, 4141, 4142, 4143, 4144, 4145, 4146, 4147, 4148, 4158, 4159, 4160, 4161, 4162, 4163, 4164, 4165, 4166, 4170, 4171, 4172, 4182, 4183, 4184, 4185, 4186, 4187, 4188, 4189, 4190, 4200, 4201, 4202, 4203, 4204, 4205, 4206, 4207, 4208, 4218, 4219, 4220, 4221, 4222, 4223, 4224, 4225, 4226, 3786, 4236, 4237, 4238, 4239, 4240, 4241, 4242, 4243, 4244, 4254, 4255, 4256, 4257, 4258, 4259, 4260, 4261, 4262, 3658, 4272, 4273, 4274, 4275, 4276, 4277, 4278, 4279, 4280, 3690, 4290, 4291, 4292, 4293, 4294, 4295, 4296, 4297, 4298, 4308, 4309, 4310, 4311, 4312, 4313, 4314, 4315, 4316, 4326, 4327, 4328, 4329, 4330, 4331, 4332, 4333, 4334 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110 ] } }, { "pk": "18", "sid": "PKDB00219", "name": "Nimmo1978", "licence": "closed", "access": "public", "date": "2019-10-25", "group_count": 1, "individual_count": 0, "intervention_count": 3, "output_count": 32, "output_calculated_count": 18, "subset_count": 2, "timecourse_count": 2, "scatter_count": 0, "reference": { "pk": 18, "study": { "sid": "PKDB00219", "name": "Nimmo1978" }, "pmid": null, "sid": "Nimmo1978", "name": "Nimmo1978", "doi": null, "title": "The influence of posture on paracetamol absorption", "abstract": null, "journal": "Br. J. clin. Pharmac.", "date": "1978-10-31", "authors": [ { "pk": 73, "first_name": "W.S.", "last_name": "Nimmo" }, { "pk": 74, "first_name": "L.F.", "last_name": "Prescott" } ] }, "reference_date": "1978-10-31", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 2.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [], "descriptions": [ { "pk": 63, "text": "Eight healthy volunteers with a mean + s.d. age of 29 ± 1.8 years and a mean + s.d. weight of 68.8 + 8.2 kg were studied twice. On one occasion the subjects were ambulant throughout the study and on the other they lay on the left side for 2 h and were then ambulant." } ], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [], "comments": [], "groups": [ 45 ] }, "individualset": null, "interventionset": { "descriptions": [], "comments": [ { "pk": 38, "username": "jbrandhorst", "text": "No food, fluid or tobacco was allowed during the study." }, { "pk": 39, "username": "jbrandhorst", "text": "On one occasion the subjects were ambulant throughout the study and on the other they lay on the left side for 2 h and were then ambulant. On both occasions, after an overnight fast, each subject was given 1.5 g paracetamol as three Panadol tablets with 200 ml water." } ], "interventions": [ 76, 78, 80 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 4337, 4338, 4357, 4358, 4359, 4360, 4361, 4362, 4372, 4373, 4374, 4375, 4376, 4377, 4378, 4379, 4380, 4351, 4352, 4353, 4354, 4355, 4356, 4390, 4391, 4392, 4393, 4394, 4395, 4396, 4397, 4398 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 111, 112 ] } }, { "pk": "19", "sid": "PKDB00131", "name": "Divoll1982", "licence": "open", "access": "public", "date": "2019-06-12", "group_count": 7, "individual_count": 1, "intervention_count": 3, "output_count": 99, "output_calculated_count": 27, "subset_count": 3, "timecourse_count": 3, "scatter_count": 0, "reference": { "pk": 19, "study": { "sid": "PKDB00131", "name": "Divoll1982" }, "pmid": "7069091", "sid": "7069091", "name": "Divoll1982", "doi": null, "title": "Age does not alter acetaminophen absorption.", "abstract": "Twenty-eight healthy volunteers (age range, 22-78 years) received 650 mg of acetaminophen (AAP) on three separate occasions. The modes of administration were 1) intravenous, 5-minute infusion; 2) oral, with two 325-mg tablets; and 3) oral, with 650 mg as an elixir preparation. Plasma levels of AAP were determined in blood samples drawn up to 12 hours after the dose. The mean (+/- sd) kinetic variables for absorption of AAP from tablets in young and elderly were peak plasma concentration, 11.8 (+/- 4.2) vs 10.9 (+/- 4.1) micrograms/ml; peak time, 0.79 (+/- .54) vs 0.69 (+/- .40) hours after the dose; absorption half-life, 12.6 (+/- 9.8) vs. 8.2 (+/- 5.3) minutes; and absolute systemic availability, 79 (+/- 9) vs 72 (+/- 11) per cent. For AAP elixir, the corresponding values were 12.6 (+/- 5.4) vs 13.7 (+/- 6.0) micrograms/ml; 0.52 (+/- .24) vs 0.54 (+/- .51) hours; 8.6 (+/- 6.2) vs 6.1 (+/- 6.6) minutes; and 87 (+/- 9) vs 80 (+/- 9) per cent. Absolute bioavailability of both oral dosage forms was significantly less then 100 per cent in all groups. Elderly subjects tended to show lower availability of both oral preparations, but the difference was of borderline significance (P less than .50). Age did not influence any other measures of absorption. Since the absorption rate of acetaminophen may be indicative of the gastric emptying rate, age does not appear to alter this rate-limiting step in drug absorption.", "journal": "Journal of the American Geriatrics Society", "date": "1982-06-24", "authors": [ { "pk": 75, "first_name": "M", "last_name": "Divoll" }, { "pk": 76, "first_name": "B", "last_name": "Ameer" }, { "pk": 77, "first_name": "D R", "last_name": "Abernethy" }, { "pk": 78, "first_name": "D J", "last_name": "Greenblatt" } ] }, "reference_date": "1982-06-24", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 3.2, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [ { "pk": 185, "name": "data/Divoll1982_Fig1.png", "file": "/media/data/Divoll1982_Fig1.png" }, { "pk": 183, "name": "data/.Divoll1982_Fig1.tsv", "file": "/media/data/.Divoll1982_Fig1.tsv" }, { "pk": 186, "name": "data/Divoll1982_Fig2.png", "file": "/media/data/Divoll1982_Fig2.png" }, { "pk": 191, "name": "data/Divoll1982.pdf", "file": "/media/data/Divoll1982.pdf" }, { "pk": 190, "name": "data/Divoll1982_Tab1.png", "file": "/media/data/Divoll1982_Tab1.png" }, { "pk": 189, "name": "data/.Divoll1982_Tab1.tsv", "file": "/media/data/.Divoll1982_Tab1.tsv" }, { "pk": 184, "name": "data/Divoll1982_Tab2.png", "file": "/media/data/Divoll1982_Tab2.png" }, { "pk": 187, "name": "data/.Divoll1982_Tab2.tsv", "file": "/media/data/.Divoll1982_Tab2.tsv" }, { "pk": 188, "name": "data/Divoll1982.xlsx", "file": "/media/data/Divoll1982.xlsx" } ], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" } ], "groupset": { "descriptions": [ { "pk": 64, "text": "Twenty-eight volunteers (age range, 22-78 years) participated in the study after giving written illformed consent. They were divided into four groups of eight young women, eight young men, six elderly women, and six elderly men." }, { "pk": 65, "text": "All 16 young subjects were free of identifiable medical disease and were not taking any drugs." }, { "pk": 66, "text": "The 12 elderly subjects were ambulatory, active, and in good general health. Three were taking drugs for cardiovascular disorclew (essential hypertension or ischemic heart disease), which were fully controlled and stable; these drugs were thiazide diuretics, digoxin, or propranolol." }, { "pk": 67, "text": "For both oral trials, the subjects fasted froin niidnight the night before and abstained from food and liquid for three hours after acetaminophen was given." } ], "comments": [ { "pk": 40, "username": "jbrandhorst", "text": "Many of the same subjects had participated in a previous study of intravenous acetaminophen." } ], "groups": [ 46, 47, 48, 49, 50, 51, 52 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 205 ] }, "interventionset": { "descriptions": [ { "pk": 68, "text": "A randomized, single-dose, three-way crossover design was used. Each subject received 650-mg doses of acetaminophen on three occasions, at least one week elapsing between trials." }, { "pk": 69, "text": "The modes of administration were as follows: 1) Intravenous acetaminophen, 13 ml of a 50 mg/ml solution diluted to 50 ml with 5 per cent dextrose, infused into an antecubital vein over a period of 5 minutes by a constant-rate infusion pump. 2) Oral acetaminophen, two 325-mg tablets* with 100-200 ml of water. 3) Oral acetaminophen, 19.5 ml of a 33.3 mg/ml solution followed by 19.5ml of water." } ], "comments": [], "interventions": [ 84, 85, 86 ] }, "outputset": { "descriptions": [ { "pk": 70, "text": "Venous blood samples were drawn into heparinized tubes from an indwelling Butterfly cannula or by venipuncture, prior to acetaminophen administration and at the following times after dosage: 0.083, 0.167, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3, 4, 6, 8, and 12 hours." } ], "comments": [], "outputs": [ 4409, 4410, 4411, 4412, 4413, 4414, 4415, 4416, 4417, 4418, 4439, 4440, 4441, 4442, 4443, 4444, 4445, 4446, 4447, 4448, 4449, 4450, 4451, 4452, 4453, 4454, 4455, 4456, 4457, 4458, 4501, 4502, 4503, 4504, 4505, 4506, 4507, 4508, 4509, 4510, 4511, 4512, 4513, 4514, 4529, 4530, 4531, 4532, 4533, 4534, 4535, 4536, 4537, 4538, 4539, 4540, 4515, 4516, 4517, 4518, 4519, 4520, 4521, 4522, 4523, 4524, 4525, 4526, 4527, 4528, 4552, 4553, 4554, 4555, 4556, 4557, 4558, 4559, 4560, 4570, 4571, 4572, 4573, 4574, 4575, 4576, 4577, 4578, 4541, 4542, 4588, 4589, 4590, 4591, 4592, 4593, 4594, 4595, 4596 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 113, 114, 115 ] } }, { "pk": "20", "sid": "PKDB00225", "name": "Nimmo1973", "licence": "closed", "access": "public", "date": "2019-10-27", "group_count": 3, "individual_count": 1, "intervention_count": 3, "output_count": 120, "output_calculated_count": 45, "subset_count": 7, "timecourse_count": 7, "scatter_count": 0, "reference": { "pk": 20, "study": { "sid": "PKDB00225", "name": "Nimmo1973" }, "pmid": "4694406", "sid": "4694406", "name": "Nimmo1973", "doi": "10.1136/bmj.1.5853.587", "title": "Pharmacological modification of gastric emptying: effects of propantheline and metoclopromide on paracetamol absorption.", "abstract": "The rate of paracetamol absorption depends on the rate of gastric emptying. Propantheline delayed gastric emptying and markedly slowed the absorption of paracetamol in six convalescent hospital patients. Conversely, the absorption of paracetamol in five healthy volunteers was accelerated by metoclopramide, a drug which stimulates gastric emptying. The total 24-hour urinary excretion of paracetamol was not influenced by propantheline or metoclopramide. Other similar absorption interactions probably occur since drugs are poorly absorbed from the stomach and many therapeutic agents influence gastrointestinal motility.", "journal": "British medical journal", "date": "1973-05-24", "authors": [ { "pk": 79, "first_name": "J", "last_name": "Nimmo" }, { "pk": 80, "first_name": "R C", "last_name": "Heading" }, { "pk": 81, "first_name": "P", "last_name": "Tothill" }, { "pk": 82, "first_name": "L F", "last_name": "Prescott" } ] }, "reference_date": "1973-05-24", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.5, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 3.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "apapcys", "name": "paracetamol cysteine", "label": "paracetamol cysteine" }, { "sid": "apapgsh", "name": "paracetamol glutathione", "label": "paracetamol glutathione" }, { "sid": "apapmer", "name": "paracetamol mercapturate", "label": "paracetamol mercapturate" }, { "sid": "metoclopramide", "name": "metoclopramide", "label": "metoclopramide" }, { "sid": "propantheline", "name": "propantheline", "label": "propantheline" } ], "groupset": { "descriptions": [ { "pk": 71, "text": "Paracetamol absorption was studied before and after metoclopramide in five healthy ambulant male volunteers aged from 22 to 39 years (mean 31 years) (group A). These subjects were known to be consistently slow absorbers of paracetamol (Prescott and Nimmo, 1971). No other drugs were being taken at the time of investigation." }, { "pk": 72, "text": "Six convalescent hospital patients aged from 22 to 80 years (mean 56 years) (group B). Informed consent was obtained. None had undergone gastrointestinal surgery, and there was no clinical evidence of renal, hepatic, gastrointestinal, or cardiac disease. All other drugs were withheld during the period of investigation." } ], "comments": [ { "pk": 41, "username": "jbrandhorst", "text": "subjects in group A were known to be consistently slow absorbers of paracetamol" }, { "pk": 42, "username": "jbrandhorst", "text": "subjects in group A were convalescent hospital patients" } ], "groups": [ 53, 54, 55 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 206 ] }, "interventionset": { "descriptions": [ { "pk": 73, "text": "Group A - After an overnight fast each healthy volunteer ingested 1.5 g of paracetamol (as three Panadol tablets) with 50 ml of water. The test was repeated not less than one week later, but on this occasion 10 mg of metoclopramide was injected intravenously at the same time as the paracetamol was taken." }, { "pk": 74, "text": "Group B: Simultaneous measurements of gastric emptying rate and paracetamol absorption were made in the patients. After an overnight fast 1-5 g of paracetamol (Panadol) was taken by mouth with 400 ml of water containing 200 microcuries of 131M In DTPA chelate. At least 48 hours later the whole procedure was repeated 15 minutes after intravenous injection of 30 mg of propantheline. One patient received paracetamol alone and on subsequent occasions was given paracetamol with propantheline and paracetamol with metoclopramide." }, { "pk": 75, "text": "Fluids were withheld for two hours after ingestion of paracetamol and tobacco and food were not allowed for four hours." } ], "comments": [], "interventions": [ 88, 90, 92 ] }, "outputset": { "descriptions": [], "comments": [ { "pk": 44, "username": "jbrandhorst", "text": "SE for recovery in Tab1, Tab2 was reduced by 3 orders of magnitude" } ], "outputs": [ 4720, 4721, 4722, 4723, 4738, 4739, 4740, 4741, 4743, 4744, 4745, 4746, 4729, 4730, 4731, 4732, 4733, 4734, 4735, 4736, 4737, 4750, 4751, 4752, 4684, 4685, 4756, 4757, 4758, 4742, 4768, 4769, 4770, 4771, 4772, 4773, 4774, 4775, 4776, 4663, 4664, 4665, 4786, 4787, 4788, 4789, 4790, 4791, 4792, 4793, 4794, 4678, 4798, 4799, 4800, 4724, 4725, 4726, 4727, 4728, 4810, 4811, 4812, 4813, 4814, 4815, 4816, 4817, 4818, 4828, 4829, 4830, 4831, 4832, 4833, 4834, 4835, 4836, 4607, 4608, 4609, 4610, 4611, 4612, 4613, 4614, 4615, 4616, 4625, 4626, 4627, 4628, 4629, 4630, 4631, 4632, 4679, 4680, 4681, 4682, 4683, 4666, 4667, 4668, 4669, 4670, 4671, 4672, 4673, 4674, 4675, 4676, 4677, 4686, 4687, 4688, 4689, 4690, 4691, 4692 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 116, 117, 118, 119, 120, 121, 122 ] } }, { "pk": "21", "sid": "PKDB00165", "name": "Prescott1973", "licence": "closed", "access": "public", "date": "2019-07-29", "group_count": 12, "individual_count": 11, "intervention_count": 1, "output_count": 95, "output_calculated_count": 24, "subset_count": 8, "timecourse_count": 8, "scatter_count": 0, "reference": { "pk": 21, "study": { "sid": "PKDB00165", "name": "Prescott1973" }, "pmid": "4788034", "sid": "4788034", "name": "Prescott1973", "doi": null, "title": "The effects of hepatic and renal damage on paracetamol metabolism and excretion following overdosage. A pharmacokinetic study.", "abstract": "1. The kinetics of paracetamol metabolism and excretion were studied in 41 patients following overdosage. Acute hepatic necrosis developed in 23 patients and in 3 of these acute renal failure also occurred. Two patients died in hepatic failure.2. Paracetamol metabolism was impaired in the patients with liver damage. The plasma half-life of the unchanged drug was significantly prolonged, and the ratio of the plasma concentrations of unchanged to conjugated paracetamol was significantly higher than in the patients without liver damage.3. Paracetamol and its conjugates were rapidly excreted in the urine. However, excretion was slower in patients with liver damage and a higher proportion was excreted unchanged.4. The renal clearance of unchanged (but not conjugated) paracetamol was related to the urine flow rate. However, forced diuresis is of no practical value and is contraindicated on clinical grounds. There was no correlation between urine pH and clearance of unchanged or conjugated drug.5. In patients with hepatic necrosis there was a marked decrease in the overall elimination rate constant which could be accounted for by decreased metabolite formation. Except in patients with acute renal failure, the urinary excretion rate constants were similar to those observed in patients without liver damage.", "journal": "British journal of pharmacology", "date": "1974-06-17", "authors": [ { "pk": 83, "first_name": "L F", "last_name": "Prescott" }, { "pk": 84, "first_name": "N", "last_name": "Wright" } ] }, "reference_date": "1974-06-17", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 2.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapcys", "name": "paracetamol cysteine", "label": "paracetamol cysteine" } ], "groupset": { "descriptions": [ { "pk": 76, "text": "Thirty females and 11 males aged 16-72 years (mean 32 years) with admission plasma paracetamol concentrations exceeding 30, ug/ml after overdosage were studied." } ], "comments": [], "groups": [ 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217 ] }, "interventionset": { "descriptions": [], "comments": [], "interventions": [ 94 ] }, "outputset": { "descriptions": [], "comments": [ { "pk": 47, "username": "jbrandhorst", "text": "With the female subjects, study days were not standardised to any particular phase of the menstrual cycle. Of the control group females four were studied in the follicular phase and four in the luteal phase, while all OCS users were studied between days 5 and 22 of the pill cycle." } ], "outputs": [ 4868, 4869, 4870, 4871, 4872, 4873, 4874, 4875, 4876, 4877, 4878, 4839, 4840, 4843, 4844, 4847, 4848, 4851, 4852, 4855, 4856, 4899, 4900, 4901, 4902, 4903, 4914, 4915, 4916, 4917, 4918, 4909, 4910, 4911, 4912, 4913, 4949, 4950, 4951, 4952, 4953, 4961, 4962, 4963, 4964, 4965, 4966, 4970, 4971, 4972, 4973, 4974, 4975, 4976, 4977, 4955, 4956, 4957, 4958, 4959, 4960, 4904, 4905, 4906, 4907, 4908, 4985, 4986, 4987, 4988, 4989, 4990, 4954, 4997, 4998, 4999, 5000, 5001, 5002, 4967, 4968, 4969, 4978, 5009, 5010, 5011, 5012, 5013, 5014, 5021, 5022, 5023, 5024, 5025, 5026 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 123, 124, 125, 126, 127, 128, 129, 130 ] } }, { "pk": "22", "sid": "PKDB00174", "name": "Triggs1975", "licence": "closed", "access": "public", "date": "2019-09-12", "group_count": 3, "individual_count": 14, "intervention_count": 4, "output_count": 191, "output_calculated_count": 27, "subset_count": 3, "timecourse_count": 3, "scatter_count": 0, "reference": { "pk": 22, "study": { "sid": "PKDB00174", "name": "Triggs1975" }, "pmid": "1233203", "sid": "1233203", "name": "Triggs1975", "doi": null, "title": "Pharmacokinetics in the elderly.", "abstract": "The pharmacokinetics of sulphamethizole, paracetamol and phenylbutazone were investigated and compared in young and geriatric subjects. The rate and extent of absorption of the drugs did not appear to be affected by increasing subject age. However, the mean half-lives for sulphamethizole and paracetamol were significantly increased in the geriatric subjects. A number of correlations are presented between the elimination rate constants of the drugs and certain subject parameters and variables. The elimination of phenylbutazone was found not to be influenced significantly by subject age. The apparent volumes of distribution of the three drugs were not age-dependent.", "journal": "European journal of clinical pharmacology", "date": "1976-12-01", "authors": [ { "pk": 85, "first_name": "E J", "last_name": "Triggs" }, { "pk": 86, "first_name": "R L", "last_name": "Nation" }, { "pk": 87, "first_name": "A", "last_name": "Long" }, { "pk": 88, "first_name": "J J", "last_name": "Ashley" } ] }, "reference_date": "1976-12-01", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 2.7, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" }, { "rating": 0.0, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" } ], "collaborators": [], "comments": [ { "pk": 48, "username": "jbrandhorst", "text": "only those subjects whose serum urea, creatinine, bilirubin, alkaline phosphatase, GOT, GPT, and plasma proteins were within normal limits were included. In addition the geriatric subjects underwent a physical examination." } ], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "apapcys", "name": "paracetamol cysteine", "label": "paracetamol cysteine" }, { "sid": "apapmer", "name": "paracetamol mercapturate", "label": "paracetamol mercapturate" }, { "sid": "sulfamethizole", "name": "sulfamethizole", "label": "sulfamethizole" }, { "sid": "sulfamethizole-acetylated", "name": "sulfamethizole acetylated", "label": "sulfamethizole acetylated" }, { "sid": "phenylbutazone", "name": "phenylbutazone", "label": "phenylbutazone" } ], "groupset": { "descriptions": [ { "pk": 77, "text": "Six young subjects acting as controls, aged 22-30 (mean 24.O) years, and seven geriatric subjects, aged 73-91 (mean 80.9) years, were selected. In an attempt to obviate any potential sex linked differences in the elimination of the drugs only male subjects were used." }, { "pk": 78, "text": "Selecting apparently healthy subjects." }, { "pk": 79, "text": "Only those subjects whose serum urea, creatinine, bilirubin, alkaline phosphatase, GOT, GPT, and plasma proteins were within normal limits were included." }, { "pk": 80, "text": "In addition the geriatric subjects underwent a physical examination. All the young subjects received no other medication for 48 hours before and during the course of the study. However, three of the geriatric subjects were receiving other drugs; subjects O.W. and E.W. were undergoing maintenance digoxin therapy, while L.F. was receiving methyldopa." } ], "comments": [], "groups": [ 68, 69, 70 ] }, "individualset": { "descriptions": [], "comments": [ { "pk": 51, "username": "jbrandhorst", "text": "subjects O.W. and E.W. were undergoing maintenance digoxin therapy, while L.F. was receiving methyldopa. " } ], "individuals": [ 218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231 ] }, "interventionset": { "descriptions": [ { "pk": 81, "text": "The drugs were administered mid-morning." }, { "pk": 82, "text": "All subjects, with the exception of one of the control group had eaten a light breakfast at least two hours prior to dosage." }, { "pk": 83, "text": "Sulphamethizole and paracetamol were administered at a dose level of 14.3 mg/kg, the former as a suspension (2.O percent) and the latter in solution (0.8 percent)." }, { "pk": 84, "text": "Phenylbutazone dosage was 5 mg/kg, the drug being packed in two hard gelatin capsules." } ], "comments": [ { "pk": 49, "username": "jbrandhorst", "text": "each of the subjects was given the three drugsby oral administration in the order sulphamethizole, paracetamol and phenylbutazone. A period of no less than six days was allowed to elapse between administration of each successive drug to any one subject." } ], "interventions": [ 96, 98, 100, 102 ] }, "outputset": { "descriptions": [], "comments": [ { "pk": 52, "username": "jbrandhorst", "text": "mysytious subject E.T. ..." } ], "outputs": [ 5053, 5054, 5055, 5056, 5057, 5058, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, 5069, 5070, 5071, 5072, 5073, 5074, 5075, 5076, 5077, 5078, 5131, 5132, 5133, 5134, 5135, 5136, 5137, 5138, 5139, 5140, 5141, 5142, 5143, 5144, 5145, 5146, 5147, 5148, 5149, 5150, 5151, 5152, 5153, 5154, 5155, 5156, 5157, 5158, 5159, 5160, 5161, 5162, 5163, 5164, 5165, 5166, 5167, 5168, 5169, 5170, 5171, 5172, 5173, 5174, 5175, 5176, 5177, 5178, 5179, 5180, 5181, 5182, 5235, 5236, 5237, 5238, 5239, 5240, 5241, 5242, 5243, 5244, 5245, 5246, 5247, 5248, 5249, 5250, 5251, 5252, 5253, 5254, 5255, 5256, 5257, 5258, 5259, 5260, 5261, 5262, 5263, 5264, 5265, 5266, 5267, 5268, 5269, 5270, 5271, 5272, 5273, 5274, 5275, 5276, 5277, 5278, 5279, 5280, 5281, 5282, 5283, 5284, 5285, 5286, 5371, 5372, 5341, 5342, 5343, 5344, 5345, 5346, 5347, 5348, 5349, 5350, 5307, 5308, 5309, 5310, 5311, 5312, 5313, 5314, 5315, 5316, 5317, 5318, 5364, 5365, 5366, 5367, 5368, 5369, 5370, 5320, 5321, 5322, 5323, 5324, 5325, 5326, 5351, 5352, 5353, 5354, 5382, 5383, 5384, 5385, 5386, 5387, 5388, 5389, 5390, 5319, 5400, 5401, 5402, 5403, 5404, 5405, 5406, 5407, 5408 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [ 131, 132, 133 ] } }, { "pk": "23", "sid": "3113968", "name": "Ullrich1987", "licence": "closed", "access": "public", "date": "2023-01-04", "group_count": 3, "individual_count": 41, "intervention_count": 1, "output_count": 51, "output_calculated_count": 0, "subset_count": 0, "timecourse_count": 0, "scatter_count": 0, "reference": { "pk": 23, "study": { "sid": "3113968", "name": "Ullrich1987" }, "pmid": "3113968", "sid": "3113968", "name": "Ullrich1987", "doi": null, "title": "Normal pathways for glucuronidation, sulphation and oxidation of paracetamol in Gilbert's syndrome.", "abstract": "A group of eleven subjects with Gilbert's syndrome was characterized by conventional tests and determination of bilirubin and its conjugates in plasma by alkaline methanolysis and thin layer chromatography. After a 1 g dose of paracetamol h.s. the drug and its metabolites were measured by high performance liquid chromatography (HPLC) in the overnight 8-h urine sample. The amounts of paracetamol and of its metabolites recovered in urine were almost identical with those found in the control group (n = 10). The glucuronide:paracetamol ratio, which is considered to be an index of glucuronidation, was not correlated with the fraction of bilirubin present in plasma as glucuronides. These data do not suggest that in subjects with Gilbert's syndrome therapeutic doses of paracetamol are associated with an increased risk for hepatic or systemic toxicity.", "journal": "European journal of clinical investigation", "date": "1987-10-19", "authors": [ { "pk": 89, "first_name": "D", "last_name": "Ullrich" }, { "pk": 90, "first_name": "A", "last_name": "Sieg" }, { "pk": 91, "first_name": "R", "last_name": "Blume" }, { "pk": 92, "first_name": "K W", "last_name": "Bock" }, { "pk": 93, "first_name": "W", "last_name": "Schröter" }, { "pk": 94, "first_name": "J", "last_name": "Bircher" } ] }, "reference_date": "1987-10-19", "creator": { "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, "curators": [ { "rating": 0.5, "username": "jbrandhorst", "first_name": "Janosch", "last_name": "Brandhorst" }, { "rating": 0.5, "username": "mkoenig", "first_name": "Matthias", "last_name": "König" } ], "collaborators": [], "comments": [], "descriptions": [], "files": [], "substances": [ { "sid": "apap", "name": "paracetamol", "label": "paracetamol" }, { "sid": "apapglu", "name": "paracetamol glucuronide", "label": "paracetamol glucuronide" }, { "sid": "apapsul", "name": "paracetamol sulfate", "label": "paracetamol sulfate" }, { "sid": "apapcys", "name": "paracetamol cysteine", "label": "paracetamol cysteine" }, { "sid": "apapmer", "name": "paracetamol mercapturate", "label": "paracetamol mercapturate" } ], "groupset": { "descriptions": [], "comments": [], "groups": [ 71, 72, 73 ] }, "individualset": { "descriptions": [], "comments": [], "individuals": [ 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272 ] }, "interventionset": { "descriptions": [], "comments": [], "interventions": [ 104 ] }, "outputset": { "descriptions": [], "comments": [], "outputs": [ 5419, 5420, 5421, 5422, 5423, 5424, 5425, 5426, 5427, 5428, 5470, 5471, 5472, 5473, 5474, 5475, 5476, 5477, 5478, 5479, 5480, 5481, 5482, 5483, 5484, 5485, 5486, 5487, 5488, 5489, 5490, 5491, 5492, 5493, 5494, 5495, 5496, 5497, 5498, 5499, 5500, 5501, 5502, 5503, 5504, 5505, 5506, 5507, 5508, 5509, 5510 ] }, "dataset": { "descriptions": [], "comments": [], "subsets": [] } } ] } }