NCT03215966View on ClinicalTrials.gov

A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

August 7, 2017

Primary Completion Date

September 24, 2017

Study Completion Date

September 24, 2017

Conditions
Healthy Subjects
Interventions
COMBINATION_PRODUCT

Macitentan / tadalafil FDC

Tablets for oral administration containing 10 mg of macitentan and 40 mg of tadalafil

DRUG

Macitentan (Opsumit®)

Film-coated tablets for oral administration formulated at a strength of 10 mg

DRUG

Tadalafil (Adcirca®)

Film-coated tablets for oral administration formulated at a strength of 20 mg

Trial Locations (1)

68167

CRS Clinical Research Services Mannheim, Mannheim

Sponsors

Lead Sponsor

Actelion
All Listed Sponsors
lead

Actelion

INDUSTRY

NCT03215966 - A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects | Biotech Hunter | Biotech Hunter