Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg

This study has been terminated.

( during Period 1 due to numerous orthostatic AEs that occurred. Subsequently, RLD was reduced to 5 mg due to safety concerns. )

First Received: March 30, 2008 Last Updated: November 19, 2009 History of Changes

Sponsor:	Mylan Pharmaceuticals
Information provided by:	Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00647972

Purpose

The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Olanzapine Tablets 20 mg Drug: Zyprexa® Tablets 20 mg	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	Single-Dose Fasting In Vivo Bioequivalence Study of Olanzapine Tablets (20 mg; Mylan) and Zyprexa® Tablets (20 mg; Eli Lilly) in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. [ Time Frame: blood collections through 144 hours ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	May 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Olanzapine Tablets 20 mg	Drug: Olanzapine Tablets 20 mg 20mg, single dose fasting
2: Active Comparator Zyprexa® Tablets 20 mg	Drug: Zyprexa® Tablets 20 mg 20mg, single dose fasting

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy, adult subjects, 18 years and older
able to swallow medication

Exclusion Criteria:

institutionalized subjects
history of any significant disease
use of any prescription or OTC medications within 14 days of start of study
received any investigational products within 30 days prior to start of study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647972

Locations

United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mylan Pharmaceuticals

Investigators

Principal Investigator:

Thomas S Clark, M.D.

Kendle International Inc.

More Information

Additional Information:

Mylan Pharmaceuticals Inc. - Clinical Trial Results This link exits the ClinicalTrials.gov site

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use This link exits the ClinicalTrials.gov site

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

FDA Enforcement Report Index This link exits the ClinicalTrials.gov site

Medwatch, FDA Safety Information and Adverse Event Reporting Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mylan Inc. ( Wayne Talton )
Study ID Numbers:	OLAN-02136
Study First Received:	March 30, 2008
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00647972 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics

Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010