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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946686
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 24, 2009
July 24, 2009
September 2002
September 2002   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets under fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
  • Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
  • Experimental: 1
    Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
    Intervention: Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
  • Active Comparator: 2
    Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
    Intervention: Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2002
September 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00946686
B023709
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: So Ran Hong, M.D. Novum Pharmaceutical Research Services
Sandoz
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP