To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®) listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided by Dongguan Dongyang Sunshine Biopharmaceutical R\&D Co., Ltd. (RD15003) pharmacokinetics and pharmacodynamic characteristics in healthy subjects, and then to evaluate the bioequivalence of test drugs and control drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
single dose, s.c. injection
single dose, s.c. injection
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Area under the plasma concentration-time curve from time zero to 24 hours
AUC0-24h
Time frame: 24 hours after injection
Area under the glucose infusion rate curve from administration to end of clamp from time zero to 24 hours
GIR-AUC0-24h
Time frame: 24 hours after injection
Area under the plasma concentration-time curve from time zero to 12 hours
AUC0-12h
Time frame: 12 hours after injection
Area under the glucose infusion rate curve from administration to end of clamp from time zero to 12 hours
AUCGIR0-12h
Time frame: 12 hours after injection
Safety evaluation
Incidence of adverse events
Time frame: Up to 24 weeks
Area under the plasma concentration-time curve from time 12 hours to 24 hours
AUC12-24h
Time frame: 12-24 hours after injection
Area under the plasma concentration-time curve from time zero to t
AUC0-t
Time frame: 120 hours after injection
Area under the glucose infusion rate curve from administration to end of clamp from time 12 hours to 24 hours
AUCGIR, 12-24h
Time frame: 12-24 hours after injection
Maximum glucose infusion rate
GIRmax
Time frame: 24 hours after injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.