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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.
Profil Mainz GmbH & Co. KG
Mainz, Rhineland-Palatinate, Germany
AUCins.0-12h
PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
Time frame: 0 -12 hours
Cins.max
PK endpoint: The maximum observed insulin concentration
Time frame: 0 -12 hours
AUCGIR.0-12h
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours
Time frame: 0 - 12 hours
GIRmax
PD endpoint: The maximum glucose infusion rate
Time frame: 0 - 12 hours
AUCins.0-2h
PK endpoint: The area under the insulin concentration curve from 0 to 2 hours
Time frame: 0 - 2 hours
AUCins.0-∞
PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
Time frame: 0 - 12 hours
tins.max
PK endpoint: The time to maximum observed insulin concentration
Time frame: Up to Day 68
t50%-ins(early)
PK endpoint: The time to half-maximum insulin concentration before Cins.max
Time frame: Up to Day 68
t50%-ins(late)
PK endpoint: The time to half-maximum insulin concentration after Cins.max
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Time frame: Up to Day 68
t½
PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz
Time frame: Up to Day 68
λz
PK endpoint: The terminal elimination rate constant of insulin
Time frame: Up to Day 68
AUCGIR.0-2h
PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours
Time frame: 0 - 2 hours
tGIR.max
PD endpoint: The time to maximum glucose infusion rate
Time frame: Up to Day 68
tGIR.50%-early
PD endpoint: The time to half-maximum glucose infusion rate before GIRmax
Time frame: Up to Day 68
tGIR.50%-late
PD endpoint: The time to half-maximum glucose infusion rate after GIRmax
Time frame: Up to Day 68
PD endpoint
time to onset of action
Time frame: Up to Day 68
Safety and local tolerability
Number of participants experiencing treatment-emergent adverse events
Time frame: Up to Day 68