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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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Aug 2022

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At a glance

  • Drugs Macitentan (Primary) ; Macitentan/tadalafil (Primary) ; Tadalafil (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Pharmacokinetics
  • Sponsors Actelion Pharmaceuticals

    • Most Recent Events

    • 24 May 2022 Status changed from recruiting to completed.
    • 26 Apr 2022 Planned primary completion date changed from 10 May 2022 to 15 May 2022.
    • 01 Mar 2022 Planned End Date changed from 10 May 2022 to 15 May 2022.

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