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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.); Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946686

B023709

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

1

Experimental group

Description:

Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

Treatment:

Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

2

Active Comparator group

Description:

Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

Treatment:

Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)