Table 7.
Regimens (test vs. reference) | Pharmacokinetic parameter | Point estimate | 95% CI |
---|---|---|---|
Heathy Japanese subjects (test) vs. healthy Western subjects (reference) (immediate-release formulation) | Dose-normalized Cmax | 1.083 | 0.935–1.255 |
Dose-normalized AUC12 | 1.176 | 1.056–1.310 | |
Heathy Chinese subjects (test) vs. healthy Western subjects (reference) (immediate-release formulation) | Dose-normalized Cmax | 1.076 | 0.838–1.382 |
Dose-normalized AUC12 | 1.029 | 0.856–1.235 |
AUC12 area under the plasma concentration–time curve from time zero to 12 h, CI confidence interval, Cmax maximum concentration