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A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

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Trial Profile

A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Jan 2025

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At a glance

  • Drugs Aripiprazole (Primary) ; Aripiprazole
  • Indications Bipolar I disorders; Schizophrenia
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

  • 20 Jan 2025 According to an Otsuka America Pharmaceutical media release, Health Canada has issued a Notice of Compliance for ABILIFY ASIMTUFII (aripiprazole prolonged release injectable suspension) for intramuscular use, a once-every-two-months treatment for schizophrenia and maintenance monotherapy of bipolar I disorder in adults.
  • 04 Apr 2023 Results of this study published in CNS Drugs.
  • 04 Apr 2023 Results presented in an Otsuka Pharmaceutical Co., Ltd., media release.

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