Completed

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 Fed Condition

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What is being tested

Etodolac Extended Release Tablets USP 600mg

+ Etodolac Extended Release Tablets 600mg

+ Etodolac Extended Release Tablets USP 600mg

Drug
Who is being recruted

Behavior

+ Feeding Behavior

+ Fasting

From 18 to 45 Years
+32 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorIPCA Laboratories Ltd.
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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 600 mg of Teva Pharmaceutical Ind. 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 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.

NCT01831687
Principal SponsorIPCA Laboratories Ltd.
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorFeeding BehaviorFasting

Criteria

12 inclusion criteria required to participate
Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight
Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or
For Female Subjects
Healthy male and non-pregnant female subjects (age range of 18 to 45 years)
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20 exclusion criteria prevent from participating
Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to dosing
Difficulty in swallowing solids like tablets or capsules
Difficulty with donating blood
Donation of blood in the past 3 months before screening
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Etodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA

Group II

Experimental
Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Veeda Clinical Research Pvt. Ltd.

Ahmedabad, IndiaOpen Veeda Clinical Research Pvt. Ltd. in Google Maps
CompletedOne Study Center