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A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants

NCT05392530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-03-30

No results posted yet for this study

Summary

The purpose of this study is to assess the rate and extent of absorption of a single oral dose of macitentan given as 2 test formulations compared to the reference formulation under fed conditions in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

Macitentan

Macitentan film coated tablets will be administered orally as per assigned treatment sequence.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Actelion Clinical Trial · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2022-08-30
Completion
2022-09-14

Countries

  • Belgium

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 NCT05392530 on ClinicalTrials.gov