Efficacy, safety, and pharmacokinetics of MR13A11A, a generic of remifentanil, for pain management of Japanese patients in the intensive care unit: a double-blinded, fentanyl-controlled, randomized, non-inferiority phase 3 study

Table 5 Pharmacokinetic parameters of remifentanil

	t_1/2	AUC_0-t	AUC_0-inf	C_max	CL	V_ss
	(min)	(min*ng/mL)	(min*ng/mL)	(ng/mL)	(mL/min/kg)	(mL/kg)
No. of patients	24	24	24	24	24	22
Mean ± SD	16.97 ± 19.81	1718 ± 2938	1726 ± 2937	1.803 ± 1.594	41.65 ± 19.70	9600 ± 16,870
(Min, Med, Max)	(4.20, 9.895, 93.7)	(85.6, 400.5, 11,800)	(87.0, 409.0, 11,800)	(0.539, 1.150, 6.08)	(19.3, 34.35, 106.0)	(292, 2125, 72,500)
Geometric mean	11.95	664.9	680.8	1.384	38.26	2960
Coefficient of variation	1.167	1.71	1.702	0.884	0.473	1.758

AUC_0-t area under the concentration–time curve from time zero to time t, AUC_0-inf AUC from time zero to infinity, CL total body clearance, C_max maximum concentration, t_1/2 elimination half-life, V_ss distribution volume at steady state

ISSN: 2052-0492