Fasting Clinical Trial
Official title:
An Open Label, Balanced, Randomized, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover, Oral Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India and Etodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA in Healthy, Adult, Human Subjects Under Fasting Condition.
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy, adult human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India and the
corresponding Reference Product: Etodolac Extended Release Tablets 600mg of Teva
Pharmaceutical Ind. Ltd., USA under fasting 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 600
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 15 days including washout period of 11
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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