Bioavailability Study of Leflunomide Tablets Under Fed Conditions

NCT00653003 | Completed Phase 1

• 1 other identifier: 2004-704
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the single-dose Bioavailability of Kali and Aventis

Conditions

To Determine Bioequivalence Under Fed Conditions

Keywords

Bioequivalence, Leflunomide, fed

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  24 Hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received Kali formulated product under fed conditions

Drug: Leflunomide

B

ACTIVE COMPARATOR

Subjects received Aventis formulated products under fed conditions

Drug: ARAVA

Interventions

Leflunomide DRUG

tablets, 20mg, single-dose

Also known as: ARAVA

A

ARAVA DRUG

Tablets, 20mg, single-dose

Also known as: Leflunomide

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Be informed of the nature of the study and given written consent prior to receiving any study procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Novum Pharmaceutical Research Services: collaborator

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xueyu Chen

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: December 1, 2003
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: September 26, 2017

Record last verified: 2017-09