NCT06553937

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

Single Dose Oral Bioequivalence Study of Macitentan and Tadalafil Filmcoated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg in Healthy Adult Male Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 fed conditions.

Conditions

• PAH

Interventions

Type	Name	Description
DRUG	Macitentan and Tadalafil	1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg
DRUG	PrOpsynvi® Film-Coated Tablets	1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg

Timeline

• Start date: 2024-05-10
• Primary completion: 2024-06-03
• Completion: 2024-07-31
• First posted: 2024-08-14
• Last updated: 2024-09-19

Locations

1 site across 1 country: India