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Clinical trial

Single-center, Open-label, Single-dose, Two-period, Randomized, Crossover, Phase I Study to Demonstrate Bioequivalence Between a Fixed Dose Combination Product Formulation of Macitentan/Tadalafil (10 mg/40 mg) and the Free Combination of 10 mg Macitentan (Opsumit®) and 40 mg Tadalafil (Adcirca®) in Healthy Male and Female Subjects

NCT03215966 is registered in ClinicalTrials.gov with Actelion as lead sponsor.

NCT NCT03215966
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Registry record

As filed in ClinicalTrials.gov.

Title
Single-center, Open-label, Single-dose, Two-period, Randomized, Crossover, Phase I Study to Demonstrate Bioequivalence Between a Fixed Dose Combination Product Formulation of Macitentan/Tadalafil (10 mg/40 mg) and the Free Combination of 10 mg Macitentan (Opsumit®) and 40 mg Tadalafil (Adcirca®) in Healthy Male and Female Subjects
Lead sponsor
Actelion
Phase
Phase 1
Overall status
Completed
Start date
August 7, 2017
Completion date
September 24, 2017
Enrollment
38 (actual)
Sites
1

Conditions

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

healthy subjects