Back to resultsTo Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Primary Purpose
Immunosuppression, Rheumatism
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
Sponsored by
About this trial
This is an interventional treatment trial for Immunosuppression focused on measuring Immunosuppressant and Antirheumatic
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
Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00946790
Brief Title
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Official Title
Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 1993 (undefined)
Primary Completion Date
December 1993 (Actual)
Study Completion Date
December 1993 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunosuppression, Rheumatism
Keywords
Immunosuppressant and Antirheumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
171 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 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
Gerald Gantt, M.D.
Organizational Affiliation
PharmaKinetics Laboratories Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
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