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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946790
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946790

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Gerald Gantt, M.D. PharmaKinetics Laboratories, Inc.
  More Information

No publications provided

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
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Immunosuppressant and Antirheumatic

Additional relevant MeSH terms:
Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Hydroxychloroquine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 22, 2014