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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: March 27, 2017
Last verified: July 2009
July 24, 2009
March 27, 2017
September 2002
September 2002   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 11 days ]
Same as current
Complete list of historical versions of study NCT00946686 on ClinicalTrials.gov Archive Site
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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.
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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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.)
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*   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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00946686
B023709
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
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