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A Phase 1, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OLZ/SAM in Pediatric Subjects (10-12 Years Old) With Bipolar I Disorder

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Trial Profile

A Phase 1, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OLZ/SAM in Pediatric Subjects (10-12 Years Old) With Bipolar I Disorder

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Nov 2023

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At a glance

  • Drugs Olanzapine/samidorphan (Primary)
  • Indications Bipolar I disorders
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Alkermes

    • Most Recent Events

    • 21 Nov 2023 Status changed from recruiting to completed.
    • 21 Dec 2022 Planned number of patients changed from 16 to 12.
    • 10 Aug 2021 New trial record

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