drugset / Trial / NCT04963439

A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants

NCT04963439

Phase 1 Completed 16 enrolled Actelion
RandomizedCrossoverOpen-labelOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Macitentan Other / unclassified Oral

Indications

No indication recorded.