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An Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM and EU Risperdal (Sourced From Germany)

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Trial Profile

An Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM and EU Risperdal (Sourced From Germany)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Aug 2022

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At a glance

  • Drugs Risperidone (Primary) ; Risperidone (Primary)
  • Indications Schizophrenia
  • Focus Pharmacokinetics
  • Acronyms BORIS-2
  • Sponsors Rovi

Most Recent Events

  • 28 Jun 2022 Results (n=77) assessing the steady-state comparative bioavailability of Risperidone ISM and oral risperidone sourced from European Union (EU) in patients stabilized on oral risperidone treatment, as well as pro- vide evidence that the direct switch from oral risperidone to Risperidone ISM is appropriate, presented at the 15th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT) 2022.
  • 07 Jan 2022 New trial record

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