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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Macitentan / tadalafil FDC	Tablets for oral administration containing 10 mg of macitentan and 40 mg of tadalafil
DRUG	Macitentan (Opsumit®)	Film-coated tablets for oral administration formulated at a strength of 10 mg
DRUG	Tadalafil (Adcirca®)	Film-coated tablets for oral administration formulated at a strength of 20 mg

Timeline

• Start date: 2017-08-07
• Primary completion: 2017-09-24
• Completion: 2017-09-24
• First posted: 2017-07-12
• Last updated: 2025-06-22

Locations

1 site across 1 country: Germany