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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Rheumatism; Immunosuppression

Treatments: Drug: Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.); Drug: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946790

005-14-10551

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Active Comparator group

Description:

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

Treatment:

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