NCT01503398

Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Olanzapine Tablets 5 mg With Zyprexa® Tablets 5 mg in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fasting conditions and to monitor the adverse events and ensure the safety of the subjects.

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Olanzapine Tablets 5 mg of Dr. Reddy's Laboratories Limited, India, comparing with that of Zyprexa® (Olanzapine) Tablets 5 mg of Eli Lilly and Company, USA, in healthy, adult, human subjects under fasting conditions.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Olanzapine	Olanzapine Tablets, 5 mg

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2012-01-04
• Last updated: 2012-01-05

Locations

1 site across 1 country: India