Completed PHASE1 INTERVENTIONAL 2-arm 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.

Sponsor: IPCA Laboratories Ltd.

Conditions Fasting

Interventions Etodolac Tablets USP 500 mg Etodolac Tablets USP 500mg

Updated 6 times since 2017 Last updated: Nov 30, 2012 Started: May 31, 2012 Primary completion: Jul 31, 2012 Completion: Jul 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01735370, this PHASE1 trial focuses on Fasting and remains completed. Sponsored by IPCA Laboratories Ltd., it has been updated 6 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

May 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

IPCA Laboratories Ltd.

Data source: IPCA Laboratories Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Ahmedabad, India