Fed Clinical Trial
Official title:
A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg of Ipca Laboratories Ltd., With Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, in Normal, Healthy, Adult, Male and Female Human Subjects Under Fed Conditions.
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover 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, male and female human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India and the
corresponding Reference Product: Indomethacin Extended-Release Capsules USP 75 mg of Epic
Pharma, USA, under fed condition in normal, healthy, adult, male and female human subjects
in a randomized crossover study.
The study was conducted with 32 healthy adult subjects. In each study period, a single 75 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 10 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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