Bioequivalence of two esomeprazole magnesium enteric-coated formulations in healthy Chinese subjects

Table 2 Pharmacokinetics parameters of test and reference formulations of esomeprazole under fed status (pharmacokinetics analysis set)

PK parameters (unit)	mean ± SD (CV%), 1n = 32
	2n	Test formulation	2n	Control formulation
Cmax (ng/mL)	64	360.373 ± 249.7500 (69.30%)	64	390.725 ± 257.6718 (65.95%)
AUC0-t (hr*ng/mL)	64	1285.9846 ± 965.7697 (75.10%)	64	1363.9129 ± 887.0435 (65.04%)
AUC0-inf (hr*ng/mL)	63	1366.4590 ± 1014.866 (74.27%)	58	1497.9755 ± 979.5204 (65.39%)
Tmax (h)	64	5.000 (2.00, 8.00)	64	5.000 (3.00, 10.00)
%AUCex	63	4.154 ± 6.7878 (163.39%)	58	4.191 ± 5.6377 (134.53%)
λz (1/h)	63	0.5766 ± 0.1851 (32.11%)	58	0.5529 ± 0.1602 (28.98%)
t1/2 (h)	63	1.454 ± 0.9882 (67.97%)	58	1.408 ± 0.5896 (41.89%)
CL/F (L/h)	63	54.4431 ± 60.2376 (110.64%)	58	47.2423 ± 47.5796 (100.71%)
Vd/F (L)	63	101.5421 ± 111.3586 (109.67%)	58	93.9881 ± 113.9048 (121.19%)

T_max is expressed as the median (min, max).

¹n is the pharmacokinetics analysis set population.

²n is the statistical analysis population.

PK: Pharmacokinetics; SD: Standard deviation; AUC: Area under the curve.