Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fasting Condition

Fasting 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 Fasting Condition.

Status Completed

Clinical Trial Summary

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 fasting condition in healthy, adult human subjects.

Clinical Trial Description

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 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 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 12 days including washout period of 9 days between administrations of study drug in each study period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasting

• NCT number: NCT01735370
• Study type: Interventional
• Source: IPCA Laboratories Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: May 2012
• Completion date: July 2012