Rheumatoid Arthritis (RA) Clinical Trial
Official title:
Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
Verified date | May 2014 |
Source | Antares Pharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Relative Bioavailability Comparison study
Status | Completed |
Enrollment | 49 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients =18 years of age, diagnosed with Rheumatoid Arthritis Exclusion Criteria: - Pregnant females - Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Antares Pharma Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-Normalized AUC[0-Inf] for MTX | Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment | 24 Hour period | No |
Primary | Dose-Normalized AUC[0-24] for MTX | Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment | 24 Hour period | No |
Primary | Dose-Normalized Cmax for MTX | Dose-normalized maximum observed concentration (Cmax) for each treatment | 24 Hour period | No |
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