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A Single-center, Open-label, Single-sequence, 2-part Study to Investigate the Effect of 75 mg Macitentan Once Daily at Steady State on the Pharmacokinetics of Riociguat, Sildenafil, Rosuvastatin and Tadalafil in Healthy Male Subjects

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Trial Profile

A Single-center, Open-label, Single-sequence, 2-part Study to Investigate the Effect of 75 mg Macitentan Once Daily at Steady State on the Pharmacokinetics of Riociguat, Sildenafil, Rosuvastatin and Tadalafil in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 May 2021

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At a glance

  • Drugs Macitentan (Primary) ; Riociguat; Rosuvastatin; Sildenafil; Tadalafil
  • Indications Congenital heart defects; Eisenmenger complex; Heart failure; Pulmonary arterial hypertension; Pulmonary hypertension
  • Focus Pharmacokinetics
  • Sponsors Actelion Pharmaceuticals; Janssen Research & Development

Most Recent Events

  • 11 May 2021 Status changed from recruiting to completed.
  • 24 Nov 2020 Planned End Date changed from 30 Apr 2021 to 11 May 2021.
  • 27 Oct 2020 Planned End Date changed from 19 Oct 2020 to 30 Apr 2021.

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