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NCT06315283

An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia

A 21-Week, Multicenter, Open-Label, Multiple-Dose Trial to Assess the Comparative Bioavailability of Olanzapine Prolonged-Release Suspension for Subcutaneous Administration (TV-44749) to Oral Olanzapine (European Reference) in Participants With Schizophrenia
Teva Branded Pharmaceutical Products R&D, Inc.·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Schizophrenia
Drug/Device/Intervention
TV-44749
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Location
Los Alamitos,Torrance,Hollywood,Atlanta,Decatur,Marlton, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 20, 2024
End date
Apr 15, 2025
Enrollment
116 participants
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
SchizophreniaSimple schizophreniaSchizophrenia, unspecifiedOther schizophreniaParanoid schizophrenia
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06315283
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.