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

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ClinicalTrials.gov Identifier: NCT00647972
Recruitment Status : Terminated (during Period 1 due to numerous orthostatic AEs that occurred. Subsequently, RLD was reduced to 5 mg due to safety concerns.)
First Posted : April 1, 2008
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Mylan Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Olanzapine Tablets 20 mg Drug: Zyprexa® Tablets 20 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : May 2003
Actual Primary Completion Date : May 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Olanzapine Tablets 20 mg
Drug: Olanzapine Tablets 20 mg
20mg, single dose fasting
Active Comparator: 2
Zyprexa® Tablets 20 mg
Drug: Zyprexa® Tablets 20 mg
20mg, single dose fasting



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00647972     History of Changes
Other Study ID Numbers: OLAN-02136
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents