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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 Relative Oral Bioavailability of the Combination of Macitentan/Tadalafil (10 mg/20 mg) Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of 10 mg Macitentan (Opsumit®) and 20 mg Tadalafil (Adcirca®)

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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 Relative Oral Bioavailability of the Combination of Macitentan/Tadalafil (10 mg/20 mg) Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of 10 mg Macitentan (Opsumit®) and 20 mg Tadalafil (Adcirca®)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Sep 2021

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At a glance

  • Drugs Macitentan/tadalafil (Primary) ; Macitentan; Tadalafil
  • Indications Pulmonary arterial hypertension
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development

Most Recent Events

  • 28 Sep 2021 Status changed from recruiting to completed.
  • 18 May 2021 Status changed from not yet recruiting to recruiting.
  • 15 Mar 2021 Protocol amended to change study design from 2-way Crossover to 3-way crossover, number of arms decreased as reported by Clinicaltrial.gov record.

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