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Bioavailability Study of Leflunomide Tablets Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652665
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
Novum Pharmaceutical Research Services
Information provided by:
Par Pharmaceutical, Inc.

Brief Summary:
To compare the single-dose Bioavailability of Kali and Aventis

Condition or disease Intervention/treatment Phase
To Determine the Bioequivalence Study Under Fasting Drug: Leflunomide Drug: ARAVA Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fasting Conditions
Study Start Date : June 2003
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Arm Intervention/treatment
Experimental: A
Subjects received kali product under fasting conditions
Drug: Leflunomide
Tablets, 20mg, single-dose
Other Name: ARAVA

Active Comparator: B
Subjects received Aventis product under fasting conditions
Tablets, 20mg,single-dose
Other Name: Leflunomide

Primary Outcome Measures :
  1. Rate and Extend of Absorption [ Time Frame: 24 Hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652665

Sponsors and Collaborators
Par Pharmaceutical, Inc.
Novum Pharmaceutical Research Services
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Principal Investigator: So Ran Hong Novum Pharmaceutical Research Services
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Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc Identifier: NCT00652665    
Other Study ID Numbers: B033201
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: March 2008
Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence, single-dose, fasting
Additional relevant MeSH terms:
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Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs