To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

Phase 1CompletedNCT00946686

Sandoz52 enrolled

Overview

To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets under fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis Psoriatic Arthritis

Interventions

Leflunomide 20 mg Tablets (Geneva Pharmaceutical)DRUG

Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 11 days

Data from ClinicalTrials.gov

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