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Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg

NCT00648921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Olanzapine Tablets 5 mg

5mg, single dose fasting

DRUG

Zyprexa® Tablets 5 mg

5mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Thomas S Clark, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2003-07-31
Completion
2003-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648921 on ClinicalTrials.gov