Fed Clinical Trial
Official title:
An Open Label, Balanced, Randomized, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover, Oral Bioequivalence Study of Etodolac Tablets USP 500mg of Ipca Laboratories Limited, India and Etodolac Tablets USP 500mg of Taro Pharmaceutical Industries Ltd., USA in Healthy, Adult, Human Subjects Under Fed Condition.
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, 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 healthy, adult human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
Etodolac Tablets USP 500 mg of Ipca Laboratories Limited, India and the corresponding
Reference Product: Etodolac Tablets USP 500mg of Taro Pharmaceutical Industries Ltd., USA,
under fed condition in healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 36 healthy adult subjects. In each study period, a single 500
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 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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