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

Simon GrillShirin BrudererPatricia N SidhartaMariya AntonovaSusanne GlobigJames CarlsonArmin SchultzDénes Csonka

Published in: British journal of clinical pharmacology (2020)

The FDC-2 tablet containing 10 mg/40 mg of macitentan/tadalafil was bioequivalent to the free combination of 10 mg macitentan and 40 mg tadalafil (both US and EU sourced). Macitentan and tadalafil were well tolerated when administered as FDC or as a free combination.

Keyphrases

pulmonary arterial hypertension
lower urinary tract symptoms
benign prostatic hyperplasia
pulmonary hypertension