PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males
Status:
Completed
Trial end date:
2019-07-03
Target enrollment:
Participant gender:
Summary
Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin
Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference
Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin lispro preparations
To evaluate the single dose safety and local tolerability of the three insulin lispro
preparations