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NCT00647972 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00647972
Other study ID # OLAN-02136
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date May 2003

Study information
Verified date April 2024
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 32
Est. completion date
Est. primary completion date May 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Olanzapine Tablets 20 mg
20mg, single dose fasting
• Zyprexa® Tablets 20 mg
20mg, single dose fasting

Locations
Country Name City State
United States Kendle International Inc. Morgantown West Virginia

Sponsors (1)
Lead Sponsor Collaborator
Mylan Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. blood collections through 144 hours
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