An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia - Trial NCT06315283
Access comprehensive clinical trial information for NCT06315283 through Pure Global AI's free database. This Phase 1 trial is sponsored by Teva Branded Pharmaceutical Products R&D, Inc. and is currently Recruiting. The study focuses on Schizophrenia. Target enrollment is 116 participants.
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Study Focus
Sponsor & Location
Teva Branded Pharmaceutical Products R&D, Inc.
Timeline & Enrollment
Phase 1
Mar 20, 2024
Apr 15, 2025
Primary Outcome
Area under the curve (AUC) of TV-44749,AUC of oral olanzapine
Summary
The primary objective of the study is to evaluate the comparative bioavailability of TV-44749
 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants
 with schizophrenia.
 
 A secondary objective of this trial is to evaluate the safety and tolerability of multiple
 doses of TV-44749 administered sc in participants with schizophrenia.
 
 Another secondary objective of this trial is to compare additional pharmacokinetic parameters
 of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants
 with schizophrenia.
 
 The total duration of participation in the trial for each participant is planned to be
 approximately 21 weeks.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06315283
Non-Device Trial