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A Single-center, Open-label, Randomized, Two-period, Two-treatment, Crossover Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg (Reference Drug) or as Single Tablet of 1600 μg (Test Drug)

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Trial Profile

A Single-center, Open-label, Randomized, Two-period, Two-treatment, Crossover Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg (Reference Drug) or as Single Tablet of 1600 μg (Test Drug)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Jul 2015

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At a glance

  • Drugs Selexipag (Primary)
  • Indications Arteriosclerosis obliterans; Pulmonary arterial hypertension; Pulmonary hypertension; Raynaud's disease
  • Focus Pharmacokinetics
  • Sponsors Actelion Pharmaceuticals

    • Most Recent Events

    • 08 Jul 2015 Results published in the International Journal of Clinical Pharmacology and Therapeutics.
    • 05 Aug 2014 New trial record
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