Omeprazole plasma concentrations coadministered with placebo or clopidogrel in studies 1, 2, and 3 (see Materials and Methods)
Data are arithmetic means (S.D.).
| Treatment | Day −5 T2a | Day 1, T2b | Day 4, T12 | Day 5, T2 |
|---|---|---|---|---|
| ng/ml | ||||
| Study 1 | ||||
| Omeprazole + clopidogrel (n = 64) | 1220 (1080) | 2790 (1380) | 2890 (1330) | |
| Omeprazole + placebo (n = 5) | 1490 (809) | 2290 (2080) | 3210 (2120) | |
| Ratioc (P valued) | 1.22 (P = 0.449) | 0.90 (P = 0.619) | ||
| Study 2e | ||||
| Omeprazole + clopidogrel (n = 66) | 768 (977) | 388 (615) | 319 (304) | 997 (1140) |
| Omeprazole + placebo (n = 6) | 337 (274) | 326 (444) | 274 (235) | 1640 (1170) |
| Ratioc (P valued) | 1.19 (P = 0.812) | 1.16 (P = 0.727) | 0.61 (P = 0.189) | |
| Study 3 | ||||
| Omeprazole + clopidogrel (n = 66) | 1320 (966) | 2290 (1080) | 2460 (1020) | |
| Omeprazole + placebo (n = 6) | 1740 (1040) | 2650 (1350) | 3080 (763) | |
| Ratioc (P valued) | 0.86 (P = 0.449) | 0.80 (P = 0.152) | ||
↵a Omeprazole alone, first day of administration.
↵b First day of clopidogrel administration, coadministered with omeprazole.
↵c Ratio of arithmetic means.
↵d Testing the equality of means between two treatments.
↵e In study 2, concentrations reported at 2 h after dose of omeprazole were lower than those reported for omeprazole administered in a fasted state (studies 1 and 3). This is probably due to the administration in a nonfasted state, because dinner was provided commencing 2 h before omeprazole administration, and food appears to increase tmax (up to 4 h) and decrease Cmax. In this study, variability observed between day 1 and day 5 is likely to stem from food effect.