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Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
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.
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
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-03-28
Completion Date
2025-06-12
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
TV-44749 318mg
Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection
Oral Olanzapine 10mg/day
Pharmaceutical form: tablet Route of administration: oral
TV-44749 425mg
Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection
Oral Olanzapine 15mg/day
Pharmaceutical form: tablet Route of administration: oral
TV-44749 531mg
Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection
Oral Olanzapine 20mg/day
Pharmaceutical form: tablet Route of administration: oral
Locations (6)
Teva Investigational Site 88049
Beijing, China
Teva Investigational Site 88048
Beijing, China
Teva Investigational Site 88047
Guangzhou, China
Teva Investigational Site 88046
Shanghai, China
Teva Investigational Site 88050
Wuhan, China
Teva Investigational Site 88056
Xi'an, China