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Bioavailability Study of Leflunomide Tablets Under Fed Conditions

NCT00653003 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-09-26

No results posted yet for this study

Summary

To compare the single-dose Bioavailability of Kali and Aventis

Conditions

  • To Determine Bioequivalence Under Fed Conditions

Interventions

DRUG

Leflunomide

tablets, 20mg, single-dose

DRUG

ARAVA

Tablets, 20mg, single-dose

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Xueyu Chen · Pharma Medica Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2004-01-31
Completion
2004-01-31

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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 NCT00653003 on ClinicalTrials.gov