Table 2.
GMR of omeprazole Cmax and AUCt in the inhibition and induction studies
| Parameters | Dose | Omeprazole alone (day 0 or 1), GMR | With perpetrator (day 8 or 9), GMR | GMR (90% CI)a | Wilcoxon signed-rank test (P-value)b | |
|---|---|---|---|---|---|---|
| Inhibition | Cmax (ng/mL) | Microdose | 1.1 | 2.39 | 2.17 (1.39–3.39) | 0.563 |
| Regular dose | 367.44 | 986.1 | 2.68 (1.57–4.58) | |||
| AUCt (ng⋅h/mL) | Microdose | 1.27 | 5.14 | 4.07 (1.99–8.33) | 0.688 | |
| Regular dose | 854.9 | 3,702.38 | 4.33 (2.78–6.7) | |||
| Induction | Cmax (ng/mL) | Microdose | 1.55 | 0.4 | 0.26 (0.16–0.42) | 0.813 |
| Regular dose | 402.03 | 83.78 | 0.21 (0.1–0.42) | |||
| AUCt (ng⋅h/mL) | Microdose | 1.64 | 0.25 | 0.16 (0.12–0.2) | >0.999 | |
| Regular dose | 990.57 | 148.4 | 0.15 (0.11–0.2) |
Notes:
a
With perpetrator/omeprazole alone;
b
comparing GMR of pharmacokinetic parameters in microdose and regular-dose conditions.
Abbreviations: AUCt, area under the (plasma concentration–time) curve until last measurable concentration; CI, confidence interval; Cmax, maximum plasma concentration; GMR, geometric mean ratio.