Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goals of this study are to:

Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these levels to the amount of olanzapine in the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

• Patients must have schizophrenia or schizoaffective disorders.

• Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent.

• Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry.

• Female patients must not be pregnant or breast-feeding.

• Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or schizoaffective disorder.