The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Beijing Hospital
Beijing, China
Cmax
the peak concentration
Time frame: Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes;
AUC 0-8 h
the AUC for insulin from time zero to 8 hours
Time frame: Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes;
AUCGIR,0-8 h
Time frame: Pre-dose, 0-8 hours
GIRmax
Time frame: Pre-dose, 0-8 hours
Tmax
time to Cmax
Time frame: Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300,330,360,420,480 minutes;
AUC 0-2 h
the AUC for insulin from time zero to 2 hours
Time frame: Pre-dose, 5,10,20,30,40,50,60,75,90,105,120 minutes
the elimination half-life (t1/2) of serum insulin
Time frame: Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes;
the AUC for insulin from time zero to 4 h
Time frame: Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240 minutes
the AUC for insulin from time zero to infinite time
Time frame: Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes;
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AUCGIR,0-2 h
Time frame: Pre-dose, 0-2 hours
AUCGIR,0-4 h
Time frame: Pre-dose, 0-4 hours
tGIRmax
Time frame: Pre-dose, 0-8 hours