NCT04540744View on ClinicalTrials.gov

A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

August 8, 2021

Study Completion Date

August 30, 2021

Conditions
Healthy
Interventions
DRUG

FDC of macitentan/tadalafil (10 mg/20 mg)

FDC of macitentan/tadalafil (10 mg/20 mg) tablet will be administered orally as per assigned treatment sequence.

DRUG

Macitentan 10 mg

Macitentan 10 mg tablet will be administered orally as a free combination as per assigned treatment sequence.

DRUG

Tadalafil 20 mg

Tadalafil 20 mg tablet will be administered orally as a free combination as per assigned treatment sequence.

Trial Locations (1)

2170

Clinical Pharmacology Unit, Merksem

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY