PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
Status:
Completed
Trial end date:
2019-12-16
Target enrollment:
Participant gender:
Summary
Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin
Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference
Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin aspart preparations
To evaluate the single dose safety and local tolerability of the three insulin aspart
preparations