To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation Victoza ® in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Human glucagon-like peptides-1 analogue
Human glucagon-like peptides-1 analogue
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Maximum (peak) plasma drug concentration(Cmax)
Maximum (peak) plasma drug concentration
Time frame: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Time to maximum concentration
Time frame: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
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 infinity
Time frame: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Terminal disposition rate constant/terminal rate constant (λz)
Apparent end elimination rate constant
Time frame: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Elimination half-life (t1/2)
The time required for the highest concentration of the drug in plasma to decrease by half
Time frame: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Apparent total body clearance
Time frame: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent volume of distribution after non-intravenous administration (Vd/F)
Apparent volume of distribution
Time frame: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Bioavailability (systemic availability of the administered dose)
Relative bioavailability
Time frame: 0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
Adverse Event, Serious Adverse Event and Drug Combination
Monitor the safety indicators of subjects during the trial
Time frame: up to day 15
body temperature
abnormal body temperature
Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
pulse
abnormal pulse
Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
blood pressure
abnormal blood pressure
Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
clinical symptoms
Any discomfort spontaneously reported by the subject
Time frame: From the screening period to day 18 after the first administration
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Monitor the safety indicators of subjects during the trial,For example: skin, mucous membrane, head (head, eyes, ears, nose, mouth), neck, chest (chest, breast, lung, heart), abdomen (liver, gallbladder, spleen, kidney, bladder), spine, limbs, nervous system, lymph nodes, etc,and calculate the Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From the screening period to day 18 after the first administration
The Number of participants with abnormal laboratory examinations
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
Time frame: From the screening period to day 18 after the first administration