Trials / Completed
CompletedNCT04963439
A Study of Two Macitentan Pediatric 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 Relative Oral Bioavailability of Two Macitentan Pediatric Formulations
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the rate and extent of absorption of macitentan following administration of a single oral dose of macitentan formulated as final market image (FMI) (test), compared to macitentan as the clinical service formulation (CSF) under fasted conditions in healthy adult participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Macitentan | Macitentan dispersible tablets will be administered orally as per assigned treatment sequence. |
Timeline
- Start date
- 2021-07-08
- Primary completion
- 2021-09-12
- Completion
- 2021-10-05
- First posted
- 2021-07-15
- Last updated
- 2025-03-30
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04963439. Inclusion in this directory is not an endorsement.