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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00946686
Date of registration: 24/07/2009
Prospective Registration: No
Primary sponsor: Sandoz
Public title: To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Scientific title: A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Date of first enrolment: September 2002
Target sample size: 52
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00946686
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Contacts
Name:     So Ran Hong, M.D.
Address: 
Telephone:
Email:
Affiliation:  Novum Pharmaceutical Research Services
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Psoriatic Arthritis
Rheumatoid Arthritis
Intervention(s)
Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Primary Outcome(s)
Bioequivalence based on AUC and Cmax [Time Frame: 11 days]
Secondary Outcome(s)
Secondary ID(s)
B023709
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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