Pharmacokinetics and pharmacodynamics study of 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU;human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. human insulin injection 5IU
An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic euglycemic clamp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Single oral administration of human insulin enteric coated capsules in dose 16mg
Single oral administration of human insulin enteric coated capsules in dose 16mg
Single subcutaneous administration of Human Insulin Injection in dose 5IU
uijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
GIRmax
PD endpoint: The maximum glucose infusion rate
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
TGIRmax
PD endpoint: The time to maximum observed glucose infusion rate
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
AUCGIR.0-11h
PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
AUCGIR0-∞
PD endpoint: The area under the glucose infusion rate curve from 0 to infinity
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
Cmax
PK endpoint: The maximum observed insulin concentration
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
Tmax
PK endpoint: The time to maximum observed insulin concentration
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
AUCIns0-11h
PK endpoint: The area under the insulin concentration curve from 0 to 11 hours
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
AUCIns0-∞
PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
Time frame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
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