CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 106 enrolled
Drug / intervention
Olanzapine Extended Release +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06319170
NCT06319170Phase 1Completed
CompareCT.gov

A Multi-center, Open-label, Randomized, Parallel-group Trial to Characterize the Pharmacokinetics of Three SC Olanzapine Extended-release Formulations With Different Release Rates Following Single Administration in Participants With Schizophrenia or Schizoaffective Disorder

Teva Branded Pharmaceutical Products R&D LLC·interventional·Posted Mar 19, 2024·Updated Jan 26, 2026

In Brief

A Phase 1 clinical trial evaluating Olanzapine Extended Release and Olanzapine Immediate Release for Schizophrenia, Schizoaffective Disorder. Completed, enrolled 106 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20252026
First PostedMar 19, 2024
Enrollment StartMar 28, 2024
Primary CompletionJan 15, 2025
Study CompletionJan 20, 2025
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.3 years ago

Interventions

Olanzapine Extended Releasedrug

Powder and vehicle for injectable suspension

Olanzapine Immediate Releasedrug

IntraMuscular Injection