Table 2 Parameters of pharmacokinetics and pharmacodynamics.

	RD10046	NovoRapid	Ratio^a or difference^b of LS means	90% CI (ratio^a), 95% CI (difference^b)
PK parameters
N	30	30	–	–
C_max (ng/mL)	4.84 (31) 5.08^c (1.55)^d	4.78 (31) 5.00^c (1.55)^d	1.01^a	(0.93,1.11)^a
T_max (min)^e	50.3 (20.4,60.9)	50.2 (30.2,75.3)	0.00^b	(− 10,10)^b
t_1/2 (min)^c,d	39.2 (13.1)	38.0 (9.38)	–	–
AUC_IAsp,0–10h (ng/mL × min)	514 (14.6) 503^c (73.5)^d	504 (17.0) 495^c (84.0)^d	1.02^a	(0.99,1.06)^a
AUC_IAsp,0–∞ (ng/mL × min)	514 (13.9) 519^c (72.0)^d	504 (16.5) 510^c (84.0)^d	1.02	(0.99,1.06)^a
PD parameters
N	29	30	–	–
GIR_max (mg/kg/min)	7.44 (23) 7.65^c (1.74)^d	7.64 (22) 7.84^c (1.72)^d	0.98^a	(0.92,1.05)^a
tGIR_max (min)	113 (33)	104 (26)	15^b	(− 10,30)^b
T_early,50% (min)	38 (21)	38 (22)	0.13^b	(− 3.65,4.03)^b
T_late,50% (min)	227 (21)	226 (17)	0.39^b	(− 24.13,25.39)^b
T_onset (min)	16 (28)	15 (23)	0^b	(0,5)^b
AUC_GIR,0–10h (mg/kg)	1493 (31) 1558^c (478)^d	1542 (27) 1594^c (427)^d	0.97^a	(0.91,1.04)^a

Values are presented as geometric means and CV (%) unless otherwise indicated.
AUC_0–10h area under the curve from time 0 to 10 h, AUC_0–∞ area under the curve from zero to infinity, CI confidence interval, C_max maximum observed drug concentration, CV coefficient of variation, GIR glucose infusion rate, h hours, LS least squares, N number of subjects, GIR_max maximum glucose infusion rate, T_max time of maximum observed drug concentration, tGIR_max time of maximum glucose infusion rate, T_early,50% and T_late,50% time of half-maximum GIR before and after GIR_max, T_onset first time of the blood glucose declining down to the target level (0.28 mmol/L less than the baseline).
^aRatio of LS means (RD10046 divided by NovoRapid).
^bDifference between medians (RD10046—NovoRapid).
^cArithmetic mean.
^dStandard deviation.
^eMedian (range).

Quick links

Search