Brief Summary

Skip to Participation Criteria

Official Title: "A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions"

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

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: July 2006

Interventions Used in this Clinical Trial

• Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz
• Drug: Indocin 75mg SR Capsules

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Indomethacin 75mg ER Capsules
• Active Comparator: 2
  • Indocin 75mg SR Capsules

Outcome Measures for this Clinical Trial

Primary Measures

• Bioequivalence according to US FDA guidelines.
  • Time Frame: 8 days
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Sandoz Inc.
• Provider of Information About this Clinical Study
  • Eric Mittleberg, Ph.D., VP Product Development, Sandoz Inc
• Overall Official(s)
  • Anthony R Godfrey, Pharm. D., Principal Investigator, PRACS Institute, LTD.