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

Phase 1CompletedNCT00946790

Sandoz72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immunosuppression Rheumatism

Interventions

Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)DRUG

Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)DRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 171 days

Data from ClinicalTrials.gov

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