The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP® in healthy male volunteers.
The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
CJ-40001 60ug SC, IV injection
NESP 60ug SC, IV injection
Samsung Medical Center
Seoul, South Korea
Assess Cmax of darbepoetin alfa in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess Cmax of darbepoetin alfa in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Assess AUClast of darbepoetin alfa in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess AUClast of darbepoetin alfa in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
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Time frame: IV treatment:Pre-dose and after dose 12 days