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

Table 1 Pharmacokinetics parameters of test and reference formulations of esomeprazole under fasting status (pharmacokinetics analysis set)

PK parameters (unit)	mean ± SD (CV%), 1n = 32
	2n	Test formulation	2n	Reference formulation
Cmax (ng/mL)	64	1709.563 ± 650.8205 (38.07%)	64	1635.875 ± 591.2969 (36.15%)
AUC0-t (hr*ng/mL)	64	4328.5196 ± 2109.6280 (48.74%)	64	4132.7124 ± 1991.9727 (48.20%)
AUC0-inf (hr*ng/mL)	64	4395.5223 ± 2173.2633 (49.44%)	64	4187.7795 ± 2046.3196 (48.86%)
Tmax (h)	64	2.000 (1.00, 4.00)	64	2.500 (1.00, 5.00)
%AUCex	64	1.135 ± 1.8793 (165.54%)	64	1.040 ± 1.1709 (112.60%)
λz (1/h)	64	0.5685 ± 0.1969 (34.64%)	64	0.5757 ± 0.1967 (34.16%)
t1/2 (h)	64	1.366 ± 0.4855 (35.53%)	64	1.329 ± 0.3972 (29.89%)
CL/F (L/h)	64	12.3599 ± 8.6012 (69.59%)	64	13.2105 ± 9.5635 (72.39%)
Vd/F (L)	64	20.3287 ± 6.4901 (31.93%)	64	21.3166 ± 8.6636 (40.64%)

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.