This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between
Novo Nordisk Investigational Site
Hvidovre, Denmark
Area under the curve (AUC) in the interval of 0-6 hours
Cmax, maximum concentration
AUC in the interval of 0-infinity hours
tmax, time to reach Cmax
Terminal rate constant
Vz/f, volume of distribution during terminal phase
t½, terminal half-life
AUCGIR, area under the glucose infusion rate value curve
GIRmax, maximum glucose infusion rate value
tGIRmax, time to maximum glucose infusion rate value
Adverse events
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