Bioavailability Study of Leflunomide Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00652665
First received: April 1, 2008
Last updated: April 3, 2008
Last verified: March 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fasting Conditions

Resource links provided by NLM:


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
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
Drug: ARAVA
Tablets, 20mg,single-dose
Other Name: Leflunomide

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
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, see Learn About Clinical Studies.

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
  More Information

No publications provided

Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc
ClinicalTrials.gov Identifier: NCT00652665     History of Changes
Other Study ID Numbers: B033201
Study First Received: April 1, 2008
Last Updated: April 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence, single-dose, fasting

Additional relevant MeSH terms:
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014