Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin mixtures Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) versus Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France).
Double-blinded, randomized, comparative, crossover study of comparative pharmacokinetics of Rinsulin® mix 30/70, suspension for subcutaneous administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, suspension for subcutaneous administration, 100 IU / ml (Lilly France, France) using hyperinsulinemic euglycemic clamp method on healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
one subcutaneous injection at a dose of 0.4 IU/kg
one subcutaneous injection at a dose of 0.4 IU/kg
"National Medical Research Center of Endocrinology" of the Ministry of Health of the Russian Federation
Moscow, Russia
National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation
Saint Petersburg, Russia
LLC "BioEk", Russian Federation
Saint Petersburg, Russia
AUC 0-12
Total area under the curve "drug concentration - time" in the time interval from 0 to 12 h
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
Cmax
Test Drug Observed Maximum Plasma Concentration
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
GIR 0-12
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 12 h
Time frame: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
GIR 0-24
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 24 h
Time frame: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
GIR max
Maximum glucose infusion rate over the study period
Time frame: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
tGIRmax
Time to reach maximum glucose infusion rate
Time frame: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
TGIRlag
Time between the drug administration and the onset of action
Time frame: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
AUC 0-2
Total area under the curve "drug concentration - time" in the time interval from 0 to 2 h
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
AUC 0-24
Total area under the curve "drug concentration - time" in the time interval from 0 to 24 h
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
AUC 0-6
Total area under the curve "drug concentration - time" in the time interval from 0 to 6 h
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
AUC 0-∞
Total area under the curve "drug concentration - time" in the time interval from 0 h to ∞
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
mean residence time
average residence time of a drug molecule in the body
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
kel
constant for drug elimination rate
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
Tmax
Time to reach test drug Maximum Plasma Concentration
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
t1/2
Half-life of a drug tested
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
t50%-early
reaching 50% of the maximum insulin concentration before reaching Cmax
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
t50%-late
reaching 50% of the maximum insulin concentration after reaching Cmax
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
ratio Сmax/AUC0-t
relative absorption rate
Time frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h