Table 10Results of Bioequivalence Determination

Parameter Ratio of geometric means (treatment A/B; 90% CI)
FDC-2 vs. free combination
Macitentan (n = 34) Tadalafil (n = 34) ACT-132577 (n = 34)
Cmax ng/mL 1.0608 (1.0014, 1.1238)0.9015 (0.8413, 0.9661)1.0198 (0.9819, 1.0591)
AUC0-t ng h/mL 1.0038 (0.9677, 1.0413)1.0040 (0.9584, 1.0517)0.9970 (0.9651, 1.0300)
AUC0-∞ ng h/mL 1.0015 (0.9675, 1.0367)1.0047 (0.9591, 1.0525)0.9936 (0.9619, 1.0264)

AUC = area under the plasma concentration-time curve; AUC0-t = AUC from time 0 to time t of the last measured concentration above the lower limit of quantification; AUC0-∞ = AUC from time 0 to infinity; Cmax = maximum plasma concentration; CI = confidence interval; FDC-2 = fixed-dose combination (current formulation); N = maximum number of subjects with data.

Source: Grill 2020 (Grill 2020), Schultz 2018 (Schultz 2018)

From: Macitentan and Tadalafil (Opsynvi)

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Macitentan and Tadalafil (Opsynvi): CADTH Reimbursement Review: Therapeutic area: Pulmonary arterial hypertension [Internet].
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