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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00946790
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Study Description
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Brief Summary:
To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.

Condition or disease Intervention/treatment Phase
Immunosuppression Rheumatism Drug: Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.) Drug: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Study Start Date : July 1993
Actual Primary Completion Date : December 1993
Actual Study Completion Date : December 1993

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
 Drug: Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
Active Comparator: 2
Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
 Drug: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 171 days ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946790


Sponsors and Collaborators
Sandoz
Investigators
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Principal Investigator: Gerald Gantt, M.D. PharmaKinetics Laboratories Inc.
More Information
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Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946790    
Other Study ID Numbers: 005-14-10551
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: July 2009
Keywords provided by Sandoz:
Immunosuppressant and Antirheumatic
Additional relevant MeSH terms:
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Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents