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

NCT ID: NCT00946686

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2002-09-30

Brief Summary

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

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

Group Type: EXPERIMENTAL

Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

Intervention Type: DRUG

2

Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

Group Type: ACTIVE_COMPARATOR

Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

Intervention Type: DRUG

Interventions

Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

Intervention Type: DRUG

Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Sandoz Inc.

Principal Investigators

So Ran Hong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Other Identifiers

B023709

Identifier Type: -

Identifier Source: org_study_id