A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules

The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.

Completed

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening

Exclusion criteria

Positive test results for HIV or hepatitis B or C
No allergies to indomethacin or related drugs

Treatment and study plan

Indomethacin 75mg Extended-Release Capsules, Sandoz

Drug

Indocin 75mg SR Capsules

Drug

Primary outcomes

Bioequivalence according to US FDA guidelines.

Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Mar 9, 2009
Registry last updated: Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed