Fed Clinical Trial
Official title:
A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fed Condition
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 fed condition in normal, healthy, adult, human subjects.
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 fed 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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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