To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
14028 injection, single dose, s.c. injection
dulaglutide injection(TRULICITY®), single dose, s.c. injection
PKUCare Luzhong Hospital
Zibo, Shandong, China
Maximum (peak) plasma drug concentration(Cmax)
Maximum (peak) plasma drug concentration
Time frame: 0 hour (pre-dose,within 30mins) to 384 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
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 384 h
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours 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 384 hours after administration
Elimination half-life (t1/2)
Elimination half-life
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent total body clearance (CL/F)
Apparent total body clearance
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Elimination constants (λz)
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Elimination constants
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration