Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Antares Pharma Inc.38 enrolled

Overview

Pharmacokinetics (PK) study

To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

Methotrexate (MTX)DRUG

Vibex MTX Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female \>18 years of age with diagnosed Rheumatoid Arthritis(RA). Exclusion Criteria: * Chronic or acute renal disease * Any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk

Locations (1)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Outcomes

Primary Outcomes

Bioequivalence Based Upon 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

Time frame: 24 Hour period

Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX

Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC\[0-24\]/Dose) for each treatment

Time frame: 24 Hour period

Bioequivalence Based Upon Dose-Normalized Cmax for MTX

Dose-normalized maximum observed concentration for each treatment

Time frame: 24 Hour period

Data from ClinicalTrials.gov

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