To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
subcutaneously injected in a single dose of 40 mg.
subcutaneously injected in a single dose of 40 mg.
Unnamed facility
Fukuoka, Japan
Area under the serum concentration-time curve (AUC) from 0 to final sampling time point
Time frame: Day 1 to Day 71
AUC from 0 to infinity
Time frame: Day 1 to Day 71
Maximum serum concentration (Cmax)
Time frame: Day 1 to Day 71
AUC from 0 to the last measurable concentration
Time frame: Day 1 to Day 71
Time to reach the peak concentration (tmax)
Time frame: Day 1 to Day 71
Mean residence time (MRT) from 0 to final sampling time point
Time frame: Day 1 to Day 71
MRT from 0 to infinity
Time frame: Day 1 to Day 71
Elimination rate constant (kel)
Time frame: Day 1 to Day 71
Elimination half life (t1/2)
Time frame: Day 1 to Day 71
Observed clearance (CL/F)
Time frame: Day 1 to Day 71
Observed volume of distribution (V/F)
Time frame: Day 1 to Day 71
Incidence of adverse events
Time frame: Day 1 to Day 71
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