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First bioequivalence study of Dexa ODF

Trial Profile

First bioequivalence study of Dexa ODF

Planning
Phase of Trial: Phase I

Latest Information Update: 23 Jan 2019

At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Chemotherapy-induced nausea and vomiting; Croup; Hypersensitivity
  • Focus Pharmacokinetics; Registrational
  • Sponsors AcuCort
  • Most Recent Events

    • 23 Jan 2019 According to an AcuCort media release, Czech State Institute for Drug Control, SUKL has given approval to conduct this study that is planned to be the basis for a registration application for the Dexa ODF in the U.S.
    • 21 Sep 2018 According to an AcuCort media release, the company plans to start this trial in autumn 2018. This trial is expected to be completed by the end of the year 2018.
    • 07 Sep 2018 According to an AcuCort media release, the company is planning for approval from the Czech regulatory authority SUKL to start the bioequivalence study in the EU.
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