Table 4.
Relative BA of the DE tablet alone and under rabeprazole pretreatment: inferential analysis of pharmacokinetic parameters of a single 110-mg DE tablet for total and unconjugated dabigatran
| Adjusted gMean | Adjusted gMean ratio (%, DE under pretreatment/DE alone) | Two-sided 90% CI (%) | |||
|---|---|---|---|---|---|
| DE under pretreatment | DE alone | ||||
| Total dabigatran | |||||
| AUC0–tz (ng h/mL) | 192 (n = 35) | 667 (n = 36) | 28.9 | 21.3–39.0 | |
| AUC0–∞ (ng h/mL) | 215 (n = 35) | 702 (n = 36) | 30.6 | 23.3–40.2 | |
| Cmax (ng/mL) | 21.9 (n = 35) | 83.1 (n = 36) | 26.4 | 20.1–34.7 | |
| Unconjugated dabigatran | |||||
| AUC0–tz (ng h/mL) | 165 (n = 35) | 588 (n = 36) | 28.0 | 20.9–37.5 | |
| AUC0–∞ (ng h/mL) | 189 (n = 35) | 618 (n = 36) | 30.6 | 23.4–40.0 | |
| Cmax (ng/mL) | 20.1 (n = 35) | 72.9 (n = 36) | 27.6 | 21.0–36.1 | |
AUC0–tz area under the concentration–time curve from baseline to last quantifiable data point, AUC0–∞ area under the concentration–time curve from baseline extrapolated to infinity, BA bioavailability, CI confidence interval, Cmax maximum plasma concentration of dabigatran, DE dabigatran etexilate, gMean geometric mean, n number of subjects