Back to resultsTo Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Primary Purpose
Rheumatoid Arthritis, Psoriatic Arthritis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00946686
Brief Title
To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Official Title
A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets under fasting conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Intervention Type
Drug
Intervention Name(s)
Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
Intervention Type
Drug
Intervention Name(s)
Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
So Ran Hong, M.D.
Organizational Affiliation
Novum Pharmaceutical Research Services
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
We'll reach out to this number within 24 hrs