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.)
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00647972
First received: March 30, 2008
Last updated: November 19, 2009
Last verified: November 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

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

ClinicalTrials.gov processed this record on August 28, 2014