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

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

Completed

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Key information

Conditions

Immunosuppression Connective Tissue Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatism Skin and Connective Tissue Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Drug

Primary outcomes

Bioequivalence based on AUC and Cmax

Time frame: 171 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Important dates

Study start: 1993
Primary completion: 1993
Study completion: 1993
First posted: Jul 27, 2009
Registry last updated: Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed