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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Oct 2020

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At a glance

  • Drugs Macitentan/tadalafil (Primary) ; Macitentan; Tadalafil
  • Indications Pulmonary arterial hypertension
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development

Most Recent Events

  • 29 Sep 2020 Status changed from recruiting to completed.
  • 01 Jul 2020 Status changed from suspended to recruiting.
  • 29 May 2020 Planned End Date changed from 5 Apr 2020 to 31 Dec 2020.

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