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

NCT01503437 Phase 1 COMPLETED

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.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	22
Start date	2006-11
Completion	2006-12

Conditions

• Fasting

Interventions

• Olanzapine OD Tablets 5 mg

Primary outcomes

• Bioequivalence is based on Cmax and AUC parameters — 2 months

Countries

India