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

Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00946790

Enrollment

Registered

2009-07-27

Start date

1993-07-31

Completion date

1993-12-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression, Rheumatism

Keywords

Immunosuppressant and Antirheumatic

Brief summary

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

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	171 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026