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