Bioavailability Study of Leflunomide Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00653003
First received: April 1, 2008
Last updated: April 3, 2008
Last verified: April 2008
  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 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 Fed 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: 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
Experimental: A
Subjects received Kali formulated product under fed conditions
Drug: Leflunomide
tablets, 20mg, single-dose
Other Name: ARAVA
Active Comparator: B
Subjects received Aventis formulated products under fed 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 female subjects under fed conditions

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will meet all of the following criteria within 30 days prior to first drug administration(except inclusion #8)
  • Healthy, surgically sterile (hysterectomy, bilateral oophorectomy) or postmenopausal (for al least 1 year)female subjects, 18 to 65 years of age(inclusive)
  • Indicate non-child bearing status by one of the following 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.

  • Body weight within 20% of the appropriate weight for the subject's height and frame (as published in the 1983 Metropolitan Life Insurance Company Scale, Statistical Bureau)
  • Negative for:

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.

  • No significant disease or clinically significant findings in a physical examination.
  • No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram(ECG)
  • Subjects who have received leflunomide within 4 months must have an A77-1726(Metabolite) level below 0.01ug/ml and no subsequent administration of leflunomide since that test. Note: The 30 day screening limit does not apply to this inclusion criterion.
  • Be informed of the nature of the study and given written consent prior to receiving any study procedures.

Exclusion Criteria:

  • Subject fulfilling any of the following criteria will be excluded from the study.
  • Known history or presence of any clinically significant medical condition.
  • Known or suspected carcinoma.
  • Known history or presence of:
  • Hypersensitivity or idiosyncratic reaction to leflunomide and/or any other drug substances with similar activity.
  • Alcoholism within the last 12 months.
  • Drug dependence and/ or substance abuse.
  • On a special diet within 4 weeks prior to drug administration(e.g. liquid, protein, raw food diet).
  • Participated in another clinical trail or received an investigational product 30 days prior to drug administration.
  • Donated up to 250 ml of blood in the past 45 days OR donated from 250 ml to 500 ml in the past 45 days OR donated 501 ml or more of blood in the past 56 days (based on the Canadian Blood Services guideline for blood donation).
  • Requirement of any medication (prescription and/ or over-the-counter) on a routine basis, with the exception of hormonal replacement therapy, nutritional supplements and/or occasional use of common analgesics.
  • Difficulty fasting or consuming the standard meals.
  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: NCT00653003

Sponsors and Collaborators
Par Pharmaceutical, Inc.
Novum Pharmaceutical Research Services
Investigators
Principal Investigator: Xueyu Chen Pharma Medica Research Inc.
  More Information

No publications provided

Responsible Party: Dr. Alfred Elvin/Director Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00653003     History of Changes
Other Study ID Numbers: 2004-704
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, Leflunomide, fed

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

ClinicalTrials.gov processed this record on October 29, 2014