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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00946686 |
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Date of registration:
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24/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
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Scientific title:
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A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00946686 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Contacts
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Name:
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So Ran Hong, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novum Pharmaceutical Research Services |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Psoriatic Arthritis
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
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Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
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Primary Outcome(s)
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Bioequivalence based on AUC and Cmax
[Time Frame: 11 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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