Leflunomide 20 mg Tablets Under Fasting Conditions

NCT00834418 | Completed Phase 1 Results

• 1 other identifier: R02-561
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma

  Bioequivalence based on Cmax

  Blood samples collected over 72 hour period

• AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726

  Bioequivalence based on AUC0-72

  Blood samples collected over 72 hour period

Study Arms (2)

Leflunomide

EXPERIMENTAL

Leflunomide 20 mg Tablet

Drug: Leflunomide 20 mg Tablets

Arava™

ACTIVE COMPARATOR

Arava™ 20 mg Tablet

Drug: ARAVA™ 20 mg Tablets

Interventions

Leflunomide 20 mg Tablets DRUG

1 x 20 mg, single-dose fasting

Leflunomide

ARAVA™ 20 mg Tablets DRUG

1 x 20 mg, single-dose fasting

Arava™

Eligibility Criteria

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

You may qualify if:

• Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.
• Screening procedures: Each subject will complete the screening process within 28 days prior to dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
• Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
• The screening clinical laboratory procedures will include:
• Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
• Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
• HIV antibody and hepatitis B surface screens;
• Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
• Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
• Serum Pregnancy Screen (female subjects only)
• Follicle Stimulating Hormone \[FSH\] (females only to verify postmenopausal status)
• If male must be vasectomized (at least 3 months)
• If female and:
• is postmenopausal for at least 1 year; or
• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

You may not qualify if:

• Subjects with a recent history of drug or alcohol addiction or abuse.
• Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
• Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
• Subjects demonstrating a positive hepatitis B surface antigen screen or reactive HIV antibody screen.
• Subjects demonstrating a positive drug abuse screen when screened for this study.
• Female subjects who are currently breastfeeding.
• Female subjects demonstrating a positive pregnancy screen.
• Subjects with a history of allergic response(s) to leflunomide or related drugs.
• Subjects with a history of clinically significant allergies including drug allergies.
• Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).
• Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
• Subjects who report donating greater than 150 mL of blood within 30 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
• Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
• Subjects who report receiving any investigational drug within 30 days prior to dosing.
• Subjects who report taking any prescription medication in the 14 days prior to dosing, with the exception of postmenopausal women on HRT may continue their HRT and topical products without systemic absorption.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

Leflunomide

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James D. Carlson, Pharm.D.

  PRACS Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: June 1, 2002
• Primary Completion: July 1, 2002
• Study Completion: July 1, 2002
• Last Updated: August 20, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

US (1)