Objective of this pivotal study was to assess the bioequivalence between Test Product: Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Seroquel® (Quetiapine fumarate) Tablets 25 mg of M/s AstraZeneca Pharmaceuticals LP, USA, under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.~The study was conducted with 54 healthy adult subjects. In each study period, a single 25 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.~The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.