This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
192
QPS Bio-Kinetic
Springfield, Missouri, United States
RECRUITINGCmax
Maximum plasma concentration
Time frame: 105 days
AUC(0-inf)
Area under concentration-time curve extrapolated from time 0 to infinity
Time frame: 105 days
AUC(0-t)
Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
Time frame: 105 days
Emax
Maximum observed effect
Time frame: 105 days
AUEC(0-t)
Area under the effect time curve from time zero (predose) to last measured time
Time frame: 105 days
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