Fed Clinical Trial
Official title:
A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Ondansetron Tablets USP 8 mg With Zofran® 8 mg in Normal, Healthy, Adult, Human Subjects Under Fed Condition.
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over 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:
Ondansetron Tablets USP 8 mg of M/s Ipca Laboratories Limited, India and the corresponding
Reference Product: Zofran® (Ondansetron hydrochloride) 8 mg Tablets of M/s GlaxoSmithKline,
under fed condition in normal, healthy, adult, human subjects in a randomized crossover
study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 8 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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