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Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder

NCT06319170 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-01-26

Study results available
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Summary

The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine.

A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine.

Another secondary objective is to characterize the pharmacokinetics of ZYPREXA.

The planned duration of the study for each participant is 19 weeks.

Conditions

  • Schizophrenia, Schizoaffective Disorder

Interventions

DRUG

Olanzapine Extended Release

Powder and vehicle for injectable suspension

DRUG

Olanzapine Immediate Release

IntraMuscular Injection

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D LLC

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2025-01-15
Completion
2025-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319170 on ClinicalTrials.gov