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Bioavailability Study of Leflunomide Tablets Under Fed 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.
 
ClinicalTrials.gov Identifier: NCT00653003
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by:
Par Pharmaceutical, Inc.

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 4, 2008
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE December 2003
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Rate and Extend of Absorption [ Time Frame: 24 Hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Leflunomide Tablets Under Fed Conditions
Official Title  ICMJE To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fed Conditions
Brief Summary To compare the single-dose Bioavailability of Kali and Aventis
Detailed Description To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy female subjects under fed conditions
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE To Determine Bioequivalence Under Fed Conditions
Intervention  ICMJE
  • Drug: Leflunomide
    tablets, 20mg, single-dose
    Other Name: ARAVA
  • Drug: ARAVA
    Tablets, 20mg, single-dose
    Other Name: Leflunomide
Study Arms  ICMJE
  • Experimental: A
    Subjects received Kali formulated product under fed conditions
    Intervention: Drug: Leflunomide
  • Active Comparator: B
    Subjects received Aventis formulated products under fed conditions
    Intervention: Drug: ARAVA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2008)
62
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2004
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00653003
Other Study ID Numbers  ICMJE 2004-704
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Alfred Elvin/Director Biopharmaceutics, Par Pharmaceutical, Inc.
Study Sponsor  ICMJE Par Pharmaceutical, Inc.
Collaborators  ICMJE Novum Pharmaceutical Research Services
Investigators  ICMJE
Principal Investigator: Xueyu Chen Pharma Medica Research, Inc.
PRS Account Par Pharmaceutical, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP