NCT00946686

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Sep 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

Same day

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Rheumatoid ArthritisPsoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    11 days

Study Arms (2)

1

EXPERIMENTAL

Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)

2

ACTIVE COMPARATOR

Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

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

Interventions

Leflunomide 20 mg Tablets (Geneva Pharmaceutical)DRUG
1
Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)DRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, Psoriatic

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • So Ran Hong, M.D.

    Novum Pharmaceutical Research Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

September 1, 2002

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

March 28, 2017

Record last verified: 2009-07