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An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone

Trial Profile

An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Jan 2020

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At a glance

  • Drugs Risperidone (Primary) ; Risperidone
  • Indications Schizophrenia
  • Focus Pharmacokinetics; Registrational
  • Acronyms BORIS
  • Sponsors Rovi
  • Most Recent Events

    • 31 Jan 2020 According to an Rovi Media release, after the conclusion of the validation phase, the European health authorities have commenced the assessment process to grant marketing authorisation for Doria in the European Union (EU).
    • 31 Jan 2020 According to an Rovi Media release, the company has filed its application for marketing authorisation for Doria with the European health authorities, the European Medicines Agency (EMA), through the Centralised Procedure on 27 December, 2019. After passing the validation phase satisfactorily, the dossier was admitted for evaluation on 30 January, 2020.
    • 30 Jul 2019 According to an Rovi Media release, the company will include long-term safety data on more than 100 patients exposed to at least one year of treatment with Doria in the registration dossier, as recommended in the International Conference on Harmonization (ICH) Guideline E1.
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