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A Double-blind, Randomized, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macitentan and an Open-label, Randomized, Crossover, Single-dose Study to Evaluate the Effect of Food on Macitentan Pharmacokinetics, in Healthy Japanese Adult Male Participants

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A Double-blind, Randomized, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macitentan and an Open-label, Randomized, Crossover, Single-dose Study to Evaluate the Effect of Food on Macitentan Pharmacokinetics, in Healthy Japanese Adult Male Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Nov 2021

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Congenital heart defects; Eisenmenger complex; Heart failure; Pulmonary arterial hypertension; Pulmonary hypertension
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Janssen Pharmaceutical KK

    • Most Recent Events

    • 12 Jan 2021 Status changed from recruiting to completed.
    • 07 Aug 2020 New trial record

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