NCT04235439View on ClinicalTrials.gov

PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

April 23, 2019

Primary Completion Date

July 3, 2019

Study Completion Date

July 3, 2019

Conditions
Diabetes Mellitus
Interventions
DRUG

Gan & Lee Insulin Lispro Injection

All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.

Trial Locations (1)

55116

Profil Mainz GmbH & Co. KG, Mainz

Sponsors
All Listed Sponsors
lead

Gan and Lee Pharmaceuticals, USA

INDUSTRY