Pharmacokinetics and pharmacodynamics study Study of 2 formulation of insulin lispro (Insulin Lispro GEROPHARM vers. Humalog® Eli Lilly)
A randomized duble blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Lispro (LLC "GEROPHARM", Russia) versus Humalog® (Eli Lilly) in normal healthy subjects using the euglycemic clamp technique
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
28
LLL "BioEq"
Saint Petersburg, Russia
Cmax
Pharmacokinetics of insulin lispro by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time frame: -60, -30 and 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
AUC(0-t)
Pharmacokinetics of insulin Lispro by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Time frame: -60, -30 and 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
GIRmax
Pharmacodynamic of insulin lispro by Maximum Glucose Infusion Rate (GIRmax)
Time frame: 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
AUCGIR0-t
Pharmacodynamic of insulin Lispro by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Time frame: 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
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