drugset / Trial / NCT06553924
Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg
RandomizedCrossoverOpen-labelOther
Summary
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fasting conditions.
Timeline
- Start
- 2024-05-14
- Primary completion
- 2024-05-31
- Completion
- 2024-08-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Macitentan | Other / unclassified | 10 mg | Oral |
| Subject | Tadalafil | Small molecule | 40 mg | Oral |