Trial intelligence / Profile preview

Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

NCT05547100Phase 1Completed

Sponsor
Alkermes
Start
Sep 2022
Primary completion
Nov 2022
Modality
Implantable Devices, Transdermal Patches, Inhalation Devices
Countries
1
01

Overview

Phase 1, open-label, single-arm trial of olanzapine + samidorphan in schizophrenia and bipolar I disorder, sponsored by Alkermes. Primary endpoints: Area under the concentration-time curve from time zero to 48 hours post-dose, Area under the concentration-time curve from time zero to the time of the last quantifiable concentration up to 15 days and 4 more. Started Sep 2022; status: completed.

02

Drugs

olanzapine + samidorphan
03

Conditions

schizophreniabipolar I disorder

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