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PK and Safety of Lybalvi in Pediatric Bipolar I Disorder
NCT04987658Phase 1Completed
- Sponsor
- Alkermes
- Start
- Jul 2021
- Primary completion
- Aug 2023
- Modality
- Implantable Devices, Transdermal Patches, Inhalation Devices
- Countries
- 1
01
Overview
Phase 1, open-label trial of olanzapine + samidorphan in bipolar I disorder (2 arms), sponsored by Alkermes. Primary endpoints: Maximum plasma concentration observed at 3 weeks, Area under the plasma concentration-time curve at 3 weeks and 2 more. Started Jul 2021; status: completed.
02
Drugs
olanzapine + samidorphan
03
Conditions
bipolar I disorder
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