Clinical Trials/NCT00946790

NCT00946790

Completed

Phase 1

Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Sandoz0 sites72 target enrollmentStarted: July 1993Last updated: March 28, 2017

ConditionsImmunosuppression Rheumatism

InterventionsHydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)

DrugsHydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)

Overview

Phase: Phase 1
Status: Completed
Sponsor: Sandoz
Enrollment: 72
Primary Endpoint: Bioequivalence based on AUC and Cmax

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Overview

Brief Summary

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

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 19 Years to 50 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

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.

Arms & Interventions

2

Active Comparator

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

Intervention: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop) (Drug)

1

Experimental

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

Intervention: Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.) (Drug)

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time Frame: 171 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Sponsor Class

Industry

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