Back to resultsTo Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets
Primary Purpose
Inflammation
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
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 finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913224
Brief Title
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets
Official Title
A Relative Bioavailability Study of Diclofenac Sodium 50 mg Enteric-Coated Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 1993 (undefined)
Primary Completion Date
April 1993 (Actual)
Study Completion Date
April 1993 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets.
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
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
Intervention Type
Drug
Intervention Name(s)
Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
17 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul D. Larsen, M.D.
Organizational Affiliation
Red River Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets
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