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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 May 2020

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At a glance

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

    • Most Recent Events

    • 06 May 2020 Results from AC077-101 and AC077-103 demonstrating Bioequivalence of Macitentan and Tadalafil Given as Fixed-dose Combination or Single-component Tablets in Healthy Subjects, published in the British Journal of Clinical Pharmacology
    • 08 Nov 2017 Status changed from recruiting to completed.
    • 10 Aug 2017 Status changed from not yet recruiting to recruiting.

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