Back to resultsA Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
Primary Purpose
Inflammation
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Indomethacin 75mg Extended-Release Capsules, Sandoz
Indocin 75mg SR Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring Anti-inflammatory
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Indomethacin 75mg ER Capsules
Indocin 75mg SR Capsules
Outcomes
Primary Outcome Measures
Bioequivalence according to US FDA guidelines.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00858195
Brief Title
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
Official Title
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Anti-inflammatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Indomethacin 75mg ER Capsules
Arm Title
2
Arm Type
Active Comparator
Arm Description
Indocin 75mg SR Capsules
Intervention Type
Drug
Intervention Name(s)
Indomethacin 75mg Extended-Release Capsules, Sandoz
Intervention Type
Drug
Intervention Name(s)
Indocin 75mg SR Capsules
Primary Outcome Measure Information:
Title
Bioequivalence according to US FDA guidelines.
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony R Godfrey, Pharm. D.
Organizational Affiliation
PRACS Institute, LTD.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
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