To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Phase 1

Completed

• Conditions: Immunosuppression; Rheumatism
• Interventions: Drug: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop); Drug: Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)

• Registration Number: NCT00946790
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-07
• Primary Completion: 1993-12
• Study Completion: 1993-12
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

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Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)	Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
1	Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)	Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	171 days