To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
single dose, s.c. injection
single dose, s.c. injection
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Maximum (peak) plasma drug concentration(Cmax)
Maximum (peak) plasma drug concentration
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
The area under the plasma concentration curve from 0 to 72 h
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)
The area under the plasma concentration curve from 0 to ∞
Time frame: 0 hour(pre-dose,within 30mins) to infinity after administration
Time to reach maximum plasma concentration following drug administration (Tmax)
Time to maximum concentration
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Elimination half-life (t1/2)
Elimination half-life
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Apparent total body clearance (CL/F)
Apparent total body clearance
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Adverse Event, Serious Adverse Event
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Monitor the safety indicators of subjects during the trial
Time frame: Up to day 4 after the second dose.