An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Single-dose Bioequivalence Study of Quetiapine 25 mg Tablet [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 25 mg Tablet [Reference Formulation; AstraZeneca, USA] in Healthy Human Volunteers Under Fasting Condition.

NCT01634386 Phase 1 COMPLETED

Objective: Primary objective of the present study was to compare the single dose bioequivalence of Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by a washout period of 7 days. Study Design: Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study

Details

Lead sponsor	Torrent Pharmaceuticals Limited
Phase	Phase 1
Status	COMPLETED

Conditions

• Healthy

Interventions

• Torrent's Quetiapine Fumarate Tablets

Countries

India