Skip to content
Pharma Observatory a Scientist.com platform

Clinical trial

A Single-center, Open-label, Single-dose, Randomized, 3-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Combination of Macitentan/Tadalafil (10 mg/20 mg) Administered as a Fixed Dose Combination Formulation Compared to the Reference Free Combination of 10 mg Macitentan (Opsumit®) and 20 mg Tadalafil (Adcirca®) as Well as the Food Effect of the Fixed-dose Combination Formulation

NCT05236231 is registered in ClinicalTrials.gov with Actelion as lead sponsor.

NCT NCT05236231
Email me this page as a PDF

Search trials, sites, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.

Get the NCT05236231 report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

Registry record

As filed in ClinicalTrials.gov.

Title
A Single-center, Open-label, Single-dose, Randomized, 3-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Combination of Macitentan/Tadalafil (10 mg/20 mg) Administered as a Fixed Dose Combination Formulation Compared to the Reference Free Combination of 10 mg Macitentan (Opsumit®) and 20 mg Tadalafil (Adcirca®) as Well as the Food Effect of the Fixed-dose Combination Formulation
Lead sponsor
Actelion
Phase
Phase 1
Overall status
Completed
Start date
February 4, 2022
Completion date
May 14, 2022
Enrollment
40 (actual)
Sites
1

Conditions

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

healthy