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Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition

Fasting Clinical Trial

Official title:
An Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Bioequivalence Study of Olanzapine 5 mg OD Tablets With Zyprexa Zydis 5 mg Tablets in Healthy Subjects Under Fasting Conditions

Clinical Trial Summary

The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse events and ensure safety of subjects.

Clinical Trial Description

An open label, balanced, randomized, two treatment, two-sequence, two-period, single-dose, crossover comparative bioequivalence study of Olanzapine 5 mg OD Tablets, of Dr. Reddy's Laboratories Limited and Zyprexa Zydis 5 mg Tablets of Cardinal Health in healthy, human subjects under fasting conditions. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01503437
Study type Interventional
Source Dr. Reddy's Laboratories Limited
Contact
Status Completed
Phase Phase 1
Start date November 2006
Completion date December 2006
View Details
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