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Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:
A Phase 1, Single Dose, Parallel Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TV-44749, Olanzapine for Extended-Release Injectable Suspension for Subcutaneous Use, in Chinese Patients With Schizophrenia

Clinical Trial Summary

Primary Objective: To evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use in Chinese participants with schizophrenia. Secondary Objectives: - To evaluate the pharmacokinetics (PK) of single doses of TV-44749 administered sc. - To evaluate the pharmacokinetics of oral olanzapine tablets following multiple dose administration. - To monitor the safety and tolerability of multiple doses of oral olanzapine tablets given in the study.

Clinical Trial Description

The total study duration for participants is planned to be approximately 13 weeks, including 40 days of screening, 1-week oral olanzapine treatment, a 1-week washout period, 4-week TV-44749 treatment, and 2-week follow-up period after the last dosing interval. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06253546
Study type Interventional
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact Teva U.S. Medical Information
Phone 1-888-483-8279
Email USMedInfo@tevapharm.com
Status Recruiting
Phase Phase 1
Start date March 28, 2024
Completion date January 31, 2025
View Details
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