PROTOCOLO FASE I (EJEMPLO)

Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

This study has been completed.

First Received on October 21, 2004.   Last Updated on July 18, 2006

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00094640

  Purpose

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).

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Intramuscular Olanzapine Depot	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.