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A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Dispersible Final Market Image (FMI) Macitentan Tablet (4 x 2.5 mg) and the Opsumit Tablet (10 mg) in Fasted Conditions

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Trial Profile

A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Dispersible Final Market Image (FMI) Macitentan Tablet (4 x 2.5 mg) and the Opsumit Tablet (10 mg) in Fasted Conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Jan 2026

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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

  • 22 Dec 2025 According to a Nippon Shinyaku media release, company announced today that Johnson & Johnson has obtained approval from the Japans Ministry of Health, Labor and Welfare (MHLW) for Opsumit tablets 10 mg.
  • 12 Sep 2023 Primary endpoint has been met. (Area Under the Plasma Analyte Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Macitentan), as per results presented at the 2023 American College of Clinical Pharmacology Annual Meeting.
  • 12 Sep 2023 Primary endpoint has been met. (Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero To Time of the Last Quantifiable (Non-below Quantification Limit [Non-BQL]) Concentration (AUC [0-last]) of Macitentan), as per results presented at the 2023 American College of Clinical Pharmacology Annual Meeting.

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