Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Dr. Reddy's Laboratories Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2006-11 |
| Completion | 2006-12 |
Conditions
- Fed
Interventions
- Olanzapine OD Tablets 5 mg
Primary outcomes
- Bioequivalence is based on Cmax and AUC parameters — 2 months
Countries
India