NCT05433675

A Study of Two Macitentan Formulations in Healthy Adult Participants

A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Dispersible Final Market Image (FMI) Macitentan Tablet (4 x 2.5 mg) and the Opsumit Tablet (10 mg) in Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult participants in fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Macitentan	Macitentan dispersible and film-coated tablets will be administered orally as per assigned treatment sequence.

Timeline

• Start date: 2022-06-22
• Primary completion: 2022-08-31
• Completion: 2022-10-03
• First posted: 2022-06-27
• Last updated: 2025-03-30

Locations

1 site across 1 country: Belgium