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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

March 30, 2008
November 19, 2009
May 2003
May 2003   (final data collection date for primary outcome measure)
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 ]
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00647972 on ClinicalTrials.gov Archive Site
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Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg
Single-Dose Fasting In Vivo Bioequivalence Study of Olanzapine Tablets (20 mg; Mylan) and Zyprexa® Tablets (20 mg; Eli Lilly) in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Olanzapine Tablets 20 mg
    20mg, single dose fasting
  • Drug: Zyprexa® Tablets 20 mg
    20mg, single dose fasting
  • Experimental: 1
    Olanzapine Tablets 20 mg
    Intervention: Drug: Olanzapine Tablets 20 mg
  • Active Comparator: 2
    Zyprexa® Tablets 20 mg
    Intervention: Drug: Zyprexa® Tablets 20 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
Not Provided
May 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00647972
OLAN-02136
Not Provided
Wayne Talton, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Thomas S Clark, M.D. Kendle International Inc.
Mylan Pharmaceuticals
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP