clinical trial · NCT03215966
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
Actelion·phase1·completed·n = 38
Healthy SubjectsMacitentan / tadalafil FDCMacitentan (Opsumit®)Tadalafil (Adcirca®)
brief 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).
started
Aug 7, 2017
primary completion
Sep 24, 2017
completion
Sep 24, 2017
last updated
Jun 22, 2025
official title
Single-center, Open-label, Single-dose, Two-period, Randomized, Crossover, Phase I Study to Demonstrate Bioequivalence Between a Fixed Dose Combination Product Formulation of Macitentan/Tadalafil (10 mg/40 mg) and the Free Combination of 10 mg Macitentan (Opsumit®) and 40 mg Tadalafil (Adcirca®) in Healthy Male and Female Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol