drugset / Trial / NCT05236231
A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants
RandomizedCrossoverOpen-labelBasic science
Summary
The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters between macitentan and tadalafil administered as a fixed dose combination (FDC) (test) of macitentan/tadalafil and the co- administered free combination (reference) of macitentan (Opsumit) and tadalafil (Adcirca) in fasted conditions in healthy adult participants; and to evaluate the effect of food on the primary PK parameters of macitentan and tadalafil administered as an FDC of macitentan/tadalafil in fed versus fasted conditions in healthy adult participants.
Timeline
- Start
- 2022-02-04
- Primary completion
- 2022-05-13
- Completion
- 2022-05-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Macitentan | Other / unclassified | 10 mg | Oral |
| Subject | Macitentan 10 mg/Tadalafil 20mg FDC | Unknown | 10 mg | Oral |
| Subject | Macitentan 10 mg/Tadalafil 20mg FDC | Unknown | 20 mg | Oral |
| Subject | Tadalafil | Small molecule | 20 mg | Oral |
Indications
No indication recorded.