Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

Lilly

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Intramuscular Olanzapine Depot

Study type: Interventional

Funder types: Industry

Identifiers

NCT00094640

F1D-EW-LOBS

6106

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.