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A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants

NCT04963439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

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 macitentan following administration of a single oral dose of macitentan formulated as final market image (FMI) (test), compared to macitentan as the clinical service formulation (CSF) under fasted conditions in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

Macitentan

Macitentan dispersible 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
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2021-09-12
Completion
2021-10-05

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 NCT04963439 on ClinicalTrials.gov