drugset / Trial / NCT04540744
A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of this study is to assess the rate and extent of absorption of macitentan and tadalafil following administration of a single oral dose of a fixed-dose combination (FDC) of 10 milligram (mg)/20 mg macitentan/tadalafil (test), compared to the coadministration as a free combination (reference) of 10 mg macitentan and 20 mg tadalafil under fasted conditions in healthy adult participants.
Timeline
- Start
- 2021-04-30
- Primary completion
- 2021-08-08
- Completion
- 2021-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Macitentan | Other / unclassified | 10 mg | Oral |
| Subject | Tadalafil | Small molecule | 20 mg | Oral |
Indications
No indication recorded.