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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 10, 2024

Primary Completion Date

June 3, 2024

Study Completion Date

July 31, 2024

Conditions
PAH
Interventions
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

Trial Locations (1)

382210

Cliantha Research Limited, Ahmedabad

All Listed Sponsors
lead

Humanis Saglık Anonim Sirketi

INDUSTRY

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 | Biotech Hunter | Biotech Hunter