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Clinical trial

Single-center, Open-label, Single-dose, 2-period, Randomized, Crossover Phase 1 Study to Demonstrate Bioequivalence of Tadalafil Administered as a Fixed Dose Combination Formulation of Macitentan/Tadalafil (10 mg/40 mg) and as the Free Combination of 10 mg Macitentan (Opsumit) and 40 mg Tadalafil (Adcirca), and to Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Formulation of Macitentan/Tadalafil (10 mg/40 mg) in Healthy Adult Participants

NCT04235270 is registered in ClinicalTrials.gov with Janssen Research & Development, LLC as lead sponsor.

NCT NCT04235270
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Registry record

As filed in ClinicalTrials.gov.

Title
Single-center, Open-label, Single-dose, 2-period, Randomized, Crossover Phase 1 Study to Demonstrate Bioequivalence of Tadalafil Administered as a Fixed Dose Combination Formulation of Macitentan/Tadalafil (10 mg/40 mg) and as the Free Combination of 10 mg Macitentan (Opsumit) and 40 mg Tadalafil (Adcirca), and to Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Formulation of Macitentan/Tadalafil (10 mg/40 mg) in Healthy Adult Participants
Lead sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Overall status
Completed
Start date
January 17, 2020
Completion date
July 17, 2020
Enrollment
62 (actual)
Sites
1

Conditions

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

healthy