Favorite Datasets from Early Phases of Drug Research

Drug Interaction Study

Part 3 - Table 4


Eight healthy male subjects (Sub) were allocated randomly to one of two treatment sequences in a two period crossover design. The two treatment sequences were either Drug A given alone (A) in the first period followed by both Drug A and Drug C (AC) in the second period, or the reverse order was administered. A seven day washout period separated the two treatment periods. The pharmacokinetic variables area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time of Cmax (Tmax), and the elimination rate constant (ERC), were calculated for each subject in each treatment period from plasma levels of each of the parent compound (P) Drug A, and its metabolite (M), based upon plasma samples taken at 0, 10, 20, 30, 40, 50 minutes; 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose.

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Part 3 - Table 4
Drug Interaction Study
AUC Cmax Tmax ERC
(ng*hr/ml) (ng/ml) (hours) (hours^(-1))
Sub Seq Cpd AC A AC A AC A AC A
1 A/AC P 969.7 856.6 584.3 416.3 1.25 1.00 0.4540 0.5032
M 2439.0 2484.1 376.4 349.2 3.00 3.03 0.0568 0.1046
4 A/AC P 938.7 746.6 824.4 598.0 0.50 0.50 0.5228 0.3304
M 4974.3 5032.6 726.0 900.7 2.00 1.75 0.0739 0.0596
6 A/AC P 776.0 563.3 763.5 262.5 0.50 0.83 0.3403 0.4181
M 2141.3 2112.1 352.4 274.8 1.50 3.00 0.0851 0.0571
8 A/AC P 2583.5 1712.7 3047.1 1391.3 0.50 0.50 0.3357 0.3826
M 6055.3 5326.6 751.9 654.2 2.00 3.00 0.0759 0.0841
2 AC/A P 586.3 591.0 166.3 450.2 4.00 0.83 0.6023 0.4184
M 4455.1 4320.9 784.7 823.7 5.00 2.00 0.1211 0.1447
3 AC/A P 996.2 859.4 550.4 727.7 1.00 0.50 0.2230 0.2275
M 1701.2 2023.6 259.1 259.5 3.00 2.00 0.1098 0.0591
5 AC/A P 991.0 948.7 503.4 778.2 0.83 0.67 0.4119 0.2918
M 2512.4 2767.4 305.4 404.0 3.00 1.75 0.0894 0.0728
7 AC/A P 533.2 512.4 249.8 290.7 1.25 0.83 0.4314 0.6479
M 3159.7 2800.4 432.8 366.6 3.00 4.00 0.0687 0.0591


Source:

Bradstreet, T.E. (1994) "Favorite Data Sets from Early Phases of Drug Research - Part 3." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 27, 2010 - THS