drugset / Trial / NCT05433675
A Study of Two Macitentan Formulations in Healthy Adult Participants
RandomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2022-06-22
- Primary completion
- 2022-08-31
- Completion
- 2022-10-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Macitentan | Other / unclassified | 10 mg | Oral |
Indications
No indication recorded.