Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00834418 |
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Leflunomide 20 mg Tablets Drug: ARAVA™ 20 mg Tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of 20 mg Leflunomide Tablets Under Fasting Conditions |
Enrollment: | 84 |
Study Start Date: | June 2002 |
Study Completion Date: | July 2002 |
Primary Completion Date: | July 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Leflunomide 20 mg Tablets
1 x 20 mg, single-dose fasting
|
2: Active Comparator |
Drug: ARAVA™ 20 mg Tablets
1 x 20 mg, single-dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The screening clinical laboratory procedures will include:
If female and:
Exclusion Criteria:
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D. Carlson, Pharm.D. | PRACS Institute, Inc. |
Study ID Numbers: | R02-561 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00834418 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Immunologic Factors Leflunomide Healthy Antirheumatic Agents Immunosuppressive Agents |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Leflunomide Physiological Effects of Drugs |
Enzyme Inhibitors Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |