Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection
Study Details
The purpose of the study is to compare Pharmacokinetics of liquid etanercept that is administered to healthy subjects aged 18-55 by an auto-injector device and manual injection (each subject received both injections).
Protocol Summary
Ratio of the geometric means of etanercept by auto-injector to etanercept by manual injection for the PK parameter of AUC (0-t)
Timeframe: 28 days
Profile PK parameters of AUC (0-∞)
Timeframe: 28 days: timepoint at which outcome measure is assessed following each treatment arm
Safety Events measured by adverse events and how they relate to study drug
Timeframe: 28 days-timepoint at which outcome measure is assessed following each treatment arm
Measure of vital signs changes from baseline to end of each treatment period
Timeframe: Baseline and 28 days following each treatment
Any Clinically Significant changes in clinical laboratory tests will be noted
Timeframe: Collected at screening, Day -1, Day 4 after dosing each treatment period, and on day 15 after dosing in Period 2
Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment
Timeframe: Predose in each treatment period and 28 days following dosing in treatment period B
Profile PK parameters of AUC (C max )
Timeframe: 28 days: timepoint at which outcome measure is assessed following each treatment arm
PK parameters of the area under the serum drug concentration (t 1/2)
Timeframe: 28 days: timepoint at which outcome measure is assessed following each treatment arm
PK parameters of the area under the serum drug concentration (t z)
Timeframe: 28 days: timepoint at which outcome measure is assessed following each treatment arm