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

Phase 1

Completed

• Conditions: Inflammation
• Interventions: Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz; Drug: Indocin 75mg SR Capsules

• Registration Number: NCT00858195
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Indomethacin 75mg Extended-Release Capsules, Sandoz	Indomethacin 75mg ER Capsules
2	Indocin 75mg SR Capsules	Indocin 75mg SR Capsules

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA guidelines.	8 days