|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Novum Pharmaceutical Research Services |
|---|---|
| Information provided by: | Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00653003 |
Purpose
To compare the single-dose Bioavailability of Kali and Aventis
| Condition | Intervention | Phase |
|---|---|---|
|
To Determine Bioequivalence Under Fed Conditions. |
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 Fed Conditions |
| Enrollment: | 62 |
| Study Start Date: | December 2003 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Subjects received Kali formulated product under fed conditions
|
Drug: Leflunomide
tablets, 20mg, single-dose
|
|
B: Active Comparator
Subjects received Aventis formulated products under fed conditions
|
Drug: ARAVA
Tablets, 20mg, single-dose
|
To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy female subjects under fed conditions
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Indication of successful hysterectomy. No spontaneous menses for al least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone(FSH) levels within postmenopausal range. Indication of successful bilateral oophorectomy.
HIV Hepatitis B surface antigen and Hepatitis C antibody Urine tests for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
Serum HCG consistent with pregnancy.
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Par Pharmaceutical, Inc. ( Dr. Alfred Elvin/Director Biopharmaceutics ) |
| Study ID Numbers: | 2004-704 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00653003 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bioequivalence, Leflunomide, fed |
|
Malnutrition Immunologic Factors Leflunomide |
Nutrition Disorders Antirheumatic Agents Immunosuppressive Agents |
|
Malnutrition Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Leflunomide Physiological Effects of Drugs |
Nutrition Disorders Enzyme Inhibitors Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |