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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

NCT03215966 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-06-22

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate that macitentan and tadalafil administered as a fixed combination is bioequivalent to both compounds given as separate tablets given at the same doses as in the fixed combination (i.e. whether the amounts of macitentan and tadalfil which reach the blood are comparable).

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

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • JP Jones · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2017-09-24
Completion
2017-09-24

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215966 on ClinicalTrials.gov