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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Novum Pharmaceutical Research Services |
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Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00652665 |
To compare the single-dose Bioavailability of Kali and Aventis
Condition | Intervention | Phase |
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To Determine the Bioequivalence Study Under Fasting |
Drug: Leflunomide Drug: ARAVA |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment |
Official Title: | To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fasting Conditions |
Enrollment: | 52 |
Study Start Date: | June 2003 |
Study Completion Date: | July 2003 |
Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Subjects received kali product under fasting conditions
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Drug: Leflunomide
Tablets, 20mg, single-dose
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B: Active Comparator
Subjects received Aventis product under fasting conditions
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Drug: ARAVA
Tablets, 20mg,single-dose
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To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy, adult subjects under fasting conditions
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | So Ran Hong | Novum Pharmaceutical Research Services |
Principal Investigator: | So Ran Hong | Novum Pharmaceutical Research Services |
Responsible Party: | Par Pharmaceutical, Inc ( Dr. Alfred Elvin/ Director Biopharmaceutics ) |
Study ID Numbers: | B033201 |
Study First Received: | April 1, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00652665 |
Health Authority: | United States: Food and Drug Administration |
Bioequivalence, single-dose, fasting |
Leflunomide |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |