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

Study Title
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 Identifier
TV44749-BA-10196
ClinicalTrials.gov Identifier
NCT06315283
Study Status
Recruiting
Trial Condition(s)
Schizophrenia
Interventions
Drug: TV-44749
EudraCT Number
2023-505664-11-00

Study Description

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.



Key Participation Requirements

Gender
Female, Male
Age Range
18 Years to 64 Years
Trial Duration
March 20, 2024 - April 18, 2025
Phase
Phase 1

Study Type

Interventional