NCT01827865

Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition

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.

• 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, 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.

Detailed description

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.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Etodolac Extended Release Tablets USP 600mg	Etodolac Extended Release Tablets USP 600mg once a day
DRUG	Etodolac Extended Release Tablets 600mg	Etodolac Extended Release Tablets 600mg once a day

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2013-04-10
• Last updated: 2013-04-10

Locations

1 site across 1 country: India