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

Rheumatoid Arthritis Clinical Trial

Official title:

A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946686
• Other study ID #: B023709
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2009
• Last updated: March 27, 2017
• Start date: September 2002
• Est. completion date: September 2002

Study information

• Verified date: July 2009
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis

Intervention

Drug:
• Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC and Cmax		11 days