Bioequivalence of macitentan and tadalafil given as fixed‐dose combination or single‐component tablets in healthy subjects

• Published in: British journal of clinical pharmacology Vol. 86; no. 12; pp. 2424 - 2434
• Main Authors: Grill, Simon, Bruderer, Shirin, Sidharta, Patricia N., Antonova, Mariya, Globig, Susanne, Carlson, James, Schultz, Armin, Csonka, Dénes
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.12.2020
• Subjects: bioequivalence; fixed‐dose combination; macitentan; Original; pulmonary arterial hypertension; tadalafil; tadalafil; macitentan; fixed-dose combination; pulmonary arterial hypertension; bioequivalence

Aims To demonstrate the bioequivalence of macitentan/tadalafil fixed‐dose combination (FDC) tablets with single‐component tablets of macitentan and tadalafil in healthy subjects. Methods Studies AC‐077‐101 and AC‐077‐103 were single‐centre, open‐label, single‐dose, 2‐period, randomized, crossover Ph...