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drugset / Trial / NCT06319170

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

NCT06319170 ↗

Phase 1 Completed 106 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-03-28
Primary completion
2025-01-15
Completion
2025-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule 5 mg Subcutaneous
Subject Olanzapine Small molecule 425 mg Subcutaneous

Indications

schizophrenia