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Leflunomide 20 mg Tablets, Non-Fasting

NCT00834405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-08-19

Study results available
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Summary

The objective of this study is to compare the relative bioavailability of leflunomide 20 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of ARAVA 20 mg tablets (Aventis) in healthy, adult, non-smoking subjects \[females (who are unable to become pregnant) and vasectomized males\] under non-fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

ARAVA® 20 mg tablets

1 x 20 mg, single-dose non-fasting

DRUG

Leflunomide 20 mg Tablets

1 x 20 mg, single-dose non-fasting

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • David B. Erasmus, M.D. · Cetero Research, San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2002-05-31
Completion
2002-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00834405 on ClinicalTrials.gov