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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 Relative Oral Bioavailability of Macitentan 75 mg as Two Different Test Formulations Compared to the Reference Formulation

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Trial Profile

A Single-center, Open-label, Single-dose, Randomized, 3-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Relative Oral Bioavailability of Macitentan 75 mg as Two Different Test Formulations Compared to the Reference Formulation

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Mar 2024

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Congenital heart defects; Eisenmenger complex; Heart failure; Pulmonary arterial hypertension; Pulmonary hypertension
  • Focus Pharmacokinetics
  • Sponsors Actelion Pharmaceuticals

Most Recent Events

  • 08 Nov 2022 Status changed from recruiting to completed.
  • 13 Sep 2022 Planned End Date changed from 21 Aug 2022 to 16 Sep 2022.
  • 05 Jul 2022 Status changed from not yet recruiting to recruiting.

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