Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin aspart (Insulin Aspart GEROPHARM vers. NovoRapid® Penfill® Novo Nordisk)
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Aspart (LLC "GEROPHARM", Russia) versus NovoRapid® Penfill® (Novo Nordisk) in normal healthy subjects using the euglycemic clamp technique
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
26
insulin aspart in doses 0.3 IU/kg
insulin aspart in doses 0.3 IU/kg
Endocrinology Research Centre
Moscow, Russia
Almazov National Medical Research Centre
Saint Petersburg, Russia
AUC(0-t)
Pharmacokinetics of insulin aspart by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Time frame: -60, -30, 0 minutes (pre-dose) and 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 135, 150, 165, 240, 300, 360, 420 and 480 minutes post-dose
Cmax
Pharmacokinetics of insulin aspart by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time frame: -60, -30, 0 minutes (pre-dose) and 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 135, 150, 165, 240, 300, 360, 420 and 480 minutes post-dose
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