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To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets under fasting conditions.

Condition Intervention Phase
Rheumatoid Arthritis
Psoriatic Arthritis
Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2002
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Active Comparator: 2
Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00946686

Sponsors and Collaborators
Principal Investigator: So Ran Hong, M.D. Novum Pharmaceutical Research Services
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00946686     History of Changes
Other Study ID Numbers: B023709 
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on October 27, 2016