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Single-center, Open-label, Single-dose, Two-period, Randomized, Crossover, Phase I Study to Demonstrate Bioequivalence of Macitentan and Tadalafil Given as Fixed-dose Combination or Single-component Tablets in Healthy Subjects

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Trial Profile

Single-center, Open-label, Single-dose, Two-period, Randomized, Crossover, Phase I Study to Demonstrate Bioequivalence of Macitentan and Tadalafil Given as Fixed-dose Combination or Single-component Tablets in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 May 2020

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At a glance

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

Most Recent Events

  • 13 May 2020 New trial record
  • 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

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