A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Severance Hospital, Yonsei University College of Medicine
Seoul, Seodamun-gu, South Korea
AUCinf of Filgrastim
PK parameter
Time frame: 0~48 hr
Cmax of Filgrastim
PK parameter
Time frame: 0~48 hr
AUEC0-t of ANC(absolute neutrophil count)
PD parameter
Time frame: 0~120 hr
Emax of ANC(absolute neutrophil count)
PD parameter
Time frame: 0~120 hr
Tmax of Filgrastim
PK parameter
Time frame: 0~48 hr
AUC0-t of Filgrastim
PK parameter
Time frame: 0~48 hr
CL/F of Filgrastim
PK parameter
Time frame: 0~48 hr
Vd/F of Filgrastim
PD parameter
Time frame: 0~48 hr
AUEC0-t of CD34+ cell count
PD parameter
Time frame: 0~312 hr
Emax of CD34+ cell count
PD parameter
Time frame: 0~312 hr
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