Bioavailability Study of Leflunomide Tablets Under Fasting Conditions - Full Text View

Sponsors and Collaborators:	Par Pharmaceutical, Inc. Novum Pharmaceutical Research Services
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00652665

Purpose

To compare the single-dose Bioavailability of Kali and Aventis

Condition	Intervention	Phase
To Determine the Bioequivalence Study Under Fasting	Drug: Leflunomide Drug: ARAVA	Phase I

Drug Information available for: Leflunomide

U.S. FDA Resources

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

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Rate and Extend of Absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

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
A: Experimental Subjects received kali product under fasting conditions	Drug: Leflunomide Tablets, 20mg, single-dose
B: Active Comparator Subjects received Aventis product under fasting conditions	Drug: ARAVA Tablets, 20mg,single-dose

Detailed Description:

To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy, adult subjects under fasting conditions

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All subjects selected for this study will be at least 18 years of age.
Females must be physically unable to become pregnant.
Males must be vasectomized.
Each subject shall be given a general physical examination within 28 days of initiation of the study.
Such examination includes, but is not limited to, blood pressure, general observations, and history.
Each female subject will be given a serum pregnancy test as part of the pre- study screening process
At the end of study, the subject will have an exit evaluation consisting of interim history, global evaluation, clinical laboratory measurements
Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements
Clinical laboratory measurements will include hematology, clinical chemistry, urine analysis, HIV screen, hepatitis-B,C screen, drugs of abuse screen before dosing.

Exclusion Criteria:

Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction,or recent serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study
Subjects whose clinical laboratory test values are greater tahn 20% outside the normal range may be retested.If the clinical values are out side the range on retesting the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant
Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.Subjects who have a history of allergic responses to cholestyramine should be excluded from the study.
All subjects will have urine samples assayed for the presence of drugs and abuse as part of the clinical laboratory screening procedures and at check-in before dosing. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
Subjects should not have donated blood and/or plasma for at least thirty(30) days prior to the first dosing of the study.
Subjects who have taken any investigational drug within thirty(30)days prior to the first dosing of the study will not be allowed to participate.
Female subjects who are pregnant or who are able(women with child bearing potential) to become pregnant during the study will not be allowed to participate.
All female subjects will be screened for pregnancy at check-in. Subjects with positive or inconclusive results will be withdrawn from the study.
Male subjects who are physically able to father a child will not be allowed to participate. Male subjects must be vasectomized(at least 3 months) with medical verification.
Subjects who have taken any product containing leflunomide within 180 days of dosing will not be allowed to participate in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652665

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Novum Pharmaceutical Research Services

Investigators

Principal Investigator:	So Ran Hong	Novum Pharmaceutical Research Services
Principal Investigator:	So Ran Hong	Novum Pharmaceutical Research Services

More Information

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

Keywords provided by Par Pharmaceutical, Inc.:

Bioequivalence, single-dose, fasting

Study placed in the following topic categories:

Leflunomide

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009