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.

NCT01996488 Phase 1 COMPLETED

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

Details

Lead sponsor	Torrent Pharmaceuticals Limited
Phase	Phase 1
Status	COMPLETED

Conditions

• Healthy

Interventions

• Olanzapine Orally Disintegrating Tablets 5mg

Primary outcomes

• bioequivalence based on Composite of Pharmacokinetics — plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration
  bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.

Countries

India