A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
Status:
Completed
Trial end date:
2020-07-17
Target enrollment:
Participant gender:
Summary
The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic
(PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of
macitentan/tadalafil (10 milligram [mg]/40 mg) and coadministered as a free combination
(reference) of 10 mg macitentan (Opsumit) and 40 mg Canada-sourced tadalafil (Adcirca) in
fasted conditions in healthy adult participants (Group 1) and to evaluate the effect of food
on the primary PK parameters of macitentan and tadalafil administered as an FDC of
macitentan/tadalafil (10 mg/40 mg) in healthy adult participants (Group 2).