NCT04237129

PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Gan & Lee Insulin Aspart	All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.

Timeline

• Start date: 2019-08-27
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2020-01-23
• Last updated: 2020-02-13

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study