NCT06319170

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All participants received immediate-release ZYPREXA and then were randomized into 1 of 3 extended-release olanzapine formulations.

Conditions

• Schizophrenia, Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Olanzapine Extended Release	Powder and vehicle for injectable suspension
DRUG	Olanzapine Immediate Release	IntraMuscular Injection

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-01-15
• Completion: 2025-01-20
• First posted: 2024-03-19
• Last updated: 2026-01-26
• Results posted: 2026-01-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study