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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis
• Interventions: Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical); Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

• Registration Number: NCT00946686
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2002-09
• Study Completion: 2002-09
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Leflunomide 20 mg Tablets (Geneva Pharmaceutical)	Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
2	Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)	Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	11 days