NCT01735370

Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fasting Condition

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Etodolac Tablets USP 500mg	500 mg tablet once a day
DRUG	Etodolac Tablets USP 500 mg	500 mg tablet once a day

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-11-28
• Last updated: 2012-12-03

Locations

1 site across 1 country: India