Pharmacokinetics and pharmacodynamics of Rinsulin® R, injection solution, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, injection solution, 100 IU / ml (Lilly France ", France) using the euglycemic hyperinsulinemic clamp method.
A double-blind, randomized, comparative, crossover study of the pharmacokinetics and pharmacodynamics of Rinsulin® R, solution for injection, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, solution for injection, 100 IU / ml (Lilly France, France) using euglycemic hyperinsulinemic clamp method on healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
subcutaneous injection at a dose of 0.3 IU / kg
subcutaneous injection at a dose of 0.3 IU / kg
"National Medical Research Center of Endocrinology" of the Ministry of Health of the Russian Federation
Moscow, Russia
Смах
Drug Observed Maximum Plasma Concentration
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC 0-10
Total area under the curve "drug concentration - time" in the time interval from 0 to 10 h
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC GIR 0-12
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 12 h
Time frame: - 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
GIRmax
Time to reach maximum glucose infusion rate
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
tGIRmax
Time to reach maximum glucose infusion rate
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC 0-2
Total area under the curve "drug concentration - time" in the time interval from 0 to 2 h
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC 0-4
Total area under the curve "drug concentration - time" in the time interval from 0 to 4 h
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Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
AUC 0-6
Total area under the curve "drug concentration - time" in the time interval from 0 to 6 h
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
Tmax
Time to reach test drug Maximum Plasma Concentration
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
T1/2
Half-life of a test drug
Time frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
tGIRlag
Time between the drug administration and the onset of action
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC GIR 0-2
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 2 h
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC GIR 0-4
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 4 h
Time frame: - 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
AUC GIR 0-6
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 6 h
Time frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours