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
Phase of Trial: Phase I
Latest Information Update: 14 Nov 2017
At a glance
- Drugs Macitentan/tadalafil (Primary) ; Macitentan; Tadalafil
- Indications Pulmonary arterial hypertension
- Focus Pharmacokinetics
- Sponsors Actelion Pharmaceuticals
- 08 Nov 2017 Status changed from recruiting to completed.
- 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.