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Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects

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Trial Profile

Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Jan 2024

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At a glance

  • Drugs Edaravone (Primary) ; Edaravone
  • Indications Amyotrophic lateral sclerosis; Cerebral infarction; Stroke
  • Focus Pharmacokinetics
  • Sponsors Mitsubishi Tanabe Pharma Corporation
  • Most Recent Events

    • 01 May 2023 According to Mitsubishi Tanabe Pharma Corporation media release, the company obtained the approval from Authority of Switzerland (Swissmedic) to RADICAVA Oral Suspension for the indication of amyotrophic lateral sclerosis.
    • 25 Apr 2022 According to a Mitsubishi Tanabe Pharma America media release, based on data from this trial and MT-1186-A01 phase 3 trial the Swissmedic has accepted the filling for suspension formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS).
    • 03 Aug 2020 New trial record
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