Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

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).

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Adelaide, South Australia, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intramuscular Olanzapine Depot

Drug

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Completed

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Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

First posted: Oct 22, 2004
Registry last updated: Jul 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed