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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946790
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
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.
Information provided by:
Sandoz
  Purpose
To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Resource links provided by NLM:


Further study details as provided by Sandoz:

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

Enrollment: 72
Study Start Date: July 1993
Study Completion Date: December 1993
Primary Completion Date: December 1993 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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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
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
Principal Investigator: Gerald Gantt, M.D. PharmaKinetics Laboratories Inc.
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946790     History of Changes
Other Study ID Numbers: 005-14-10551
First Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Immunosuppressant and Antirheumatic

Additional relevant MeSH terms:
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