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Clinical trial

A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Dispersible Final Market Image (FMI) Macitentan Tablet (4 x 2.5 mg) and the Opsumit Tablet (10 mg) in Fasted Conditions

NCT05433675 is registered in ClinicalTrials.gov with Actelion as lead sponsor.

NCT NCT05433675
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Registry record

As filed in ClinicalTrials.gov.

Title
A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Dispersible Final Market Image (FMI) Macitentan Tablet (4 x 2.5 mg) and the Opsumit Tablet (10 mg) in Fasted Conditions
Lead sponsor
Actelion
Phase
Phase 1
Overall status
Completed
Start date
June 22, 2022
Completion date
October 3, 2022
Enrollment
28 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy