Single-center, Open-label, Single-dose, Two-period, Randomized, Crossover, Phase I Study to Demonstrate Bioequivalence Between a Fixed Dose Combination Product Formulation of Macitentan/Tadalafil (10 mg/40 mg) and the Free Combination of 10 mg Macitentan (Opsumit®) and 40 mg Tadalafil (Adcirca®) in Healthy Male and Female Subjects

Trial Profile

Single-center, Open-label, Single-dose, Two-period, Randomized, Crossover, Phase I Study to Demonstrate Bioequivalence Between a Fixed Dose Combination Product Formulation of Macitentan/Tadalafil (10 mg/40 mg) and the Free Combination of 10 mg Macitentan (Opsumit®) and 40 mg Tadalafil (Adcirca®) in Healthy Male and Female Subjects

Recruiting
Phase of Trial: Phase I

Latest Information Update: 14 Aug 2017

At a glance

  • Drugs Macitentan/tadalafil (Primary) ; Macitentan; Tadalafil
  • Indications Pulmonary arterial hypertension
  • Focus Pharmacokinetics
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 10 Aug 2017 Status changed from not yet recruiting to recruiting.
    • 03 Aug 2017 Planned initiation date changed from 3 Aug 2017 to 7 Aug 2017.
    • 18 Jul 2017 New trial record
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