NCT01996488

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fasting Condition

An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Olanzapine Orally Disintegrating 5mg Tablets (Test Formulation; Torrent Pharmaceuticals Ltd., India) Versus Zyprexa® Zydis® 5 mg Tablets (Reference Formulation; Eli Lilly and Company, USA) in Healthy Human Volunteers Under Fasting Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a washout period during fasted study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Olanzapine Orally Disintegrating Tablets 5mg

Timeline

• Primary completion: 2009-01-01
• First posted: 2013-11-27
• Last updated: 2017-10-25

Locations

1 site across 1 country: India