Overview

A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects

Status:
Completed
Trial end date:
2017-09-24
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to demonstrate that macitentan and tadalafil administered as a fixed combination is bioequivalent to both compounds given as separate tablets given at the same doses as in the fixed combination (i.e. whether the amounts of macitentan and tadalfil which reach the blood are comparable).
Phase:
Phase 1
Details
Lead Sponsor:
Actelion
Treatments:
Macitentan
Tadalafil