NCT01503450

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

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 Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 fed conditions and to monitor adverse events and ensure safety of subjects.

Detailed 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 fed conditions.

Conditions

• Fed

Interventions

Type	Name	Description
DRUG	Olanzapine OD Tablets 5 mg	Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited

Timeline

• Start date: 2006-11-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2012-01-04
• Last updated: 2012-01-05

Locations

1 site across 1 country: India