. 2011 Dec 22;14(1):68–78. doi: 10.1208/s12248-011-9316-3

Table II.

Ratios of geometric means of steady-state AUC_τ and C _tr of macitentan and its metabolites in the presence of cyclosporine or rifampin treatment (period 2) versus macitentan treatment alone (period 1)

	Statistics	Part A		Part B
		Macitentan + Cs vs macitentan		Macitentan + rifampin vs macitentan
		AUC_τ (ng·h/mL)	C _tr (ng·h/mL)	AUC_τ (ng·h/mL)	C _tr (ng·h/mL)
Macitentan	Ratio of geometric means	1.10^a	1.38^a	0.21^a	0.07^a
Macitentan	90% confidence interval	0.91–1.33	1.06–1.81	0.17–0.26	0.05–0.10
ACT-132577	Ratio of geometric means	0.97	1.02	1.00	0.83^a
ACT-132577	90% confidence interval	0.85–1.11	0.87–1.19	0.89–1.12	0.73–0.94
ACT-373898	Ratio of geometric means	1.07^a	1.12^a	0.36^a	0.14^a
ACT-373898	90% confidence interval	0.79–1.45	0.81–1.55	0.27–0.50	0.09–0.20

Part A: Ratio of geometric mean of AUC_τ in Period 2 versus Period 1: AUC_{(384h - 408h)} / AUC_{(96h - 120h)}. Ratio of geometric mean of C _tr in Period 2 versus Period 1. Part B: Ratio of geometric mean of AUC_τ in Period 2 versus Period 1: AUC_{(264h - 288h)} / AUC_{(96h - 120h)}. Ratio of geometric mean of C _tr in Period 2 versus Period 1

^aRatio of geometric means and 90% confidence intervals where at least one of the confidence limits falls outside the FDA-accepted bioequivalence range of 0.80–1.25