Favorite Datasets from Early Phases of Drug Research

Food Interaction Study

Part 2 - Table 5


Eight healthy male volunteers were allocated randomly to a two-period crossover design. Each subject followed one of two eating sequences [Fasted (-) then Fed (+), or Fed (+) then Fasted (-)]. During each study period the subjects received a single dose of a antihypertensive therapy. A five to seven day washout period separated the two study periods. The pharmacokinetic variables area under the plasma concentration by time curve (AUC), maximum plasma level (Cmax), and the time of maximum plasma level (Tmax) were calculated for each subject from plasma concentrations assayed from blood samples taken at 0, 10, 20, 30, 40, and 50 minutes; 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 30, and 36 hours post dose period. The pharmacokinetic calculations were performed both for the parent compound (P) and the metabolite (M).

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Part 2 - Table 5
Food Interaction Study
AUC Cmax Tmax
(ng*hr/ml) (ng/ml) (hours)
Sub Sequence Cpd Fed Fasted Fed Fasted Fed Fasted
1 +/- P 809.44 967.82 155.8 440.6 1.750 1.517
M 1965.17 2622.35 173.2 336.5 5.000 2.983
2 +/- P 428.00 746.45 139.1 493.3 4.000 0.833
M 3149.18 3618.60 346.2 484.6 6.000 2.000
3 -/+ P 757.71 901.11 633.0 475.5 0.833 1.250
M 2448.69 2545.05 511.5 538.4 3.000 5.000
4 -/+ P 906.83 1146.96 258.5 688.2 3.000 0.667
M 3968.34 3500.83 603.7 597.6 5.000 1.750
5 +/- P 712.24 678.16 326.5 366.6 3.000 1.667
M 3249.45 3362.40 689.3 498.1 5.000 3.000
6 -/+ P 561.77 745.51 212.6 469.9 5.000 0.667
M 2136.47 2625.75 275.5 375.9 6.000 3.000
7 +/- P 511.84 568.98 117.7 269.4 5.000 3.000
M 3694.80 4117.14 499.7 730.4 5.000 5.000
8 -/+ P 756.60 852.86 294.6 908.5 1.000 0.667
M 1517.10 2386.19 217.3 456.7 3.000 1.750


Source:

Bradstreet, T.E. (1992) "Favorite Data Sets from Early Phases of Drug Research - Part 2." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 14, 1997 - THS