delayed-release capsule formulation

Parameter (Units)	Losec^® (2x20 mg) (Reference treatment) n=25	Omeprazole 40 mg delayed-release capsule (Test treatment) n=25
AUC_last (ng*h/mL)^a	3866.1 (81)	3905.0 (67)
AUC_inf (ng*h/mL)^a	3944.2 (83)	3983.8 (71)
C_max (ng/mL)^a	1339.4 (45)	1212.0 (44)
T_max (h)^b	2.5 [1.5–4.0]	3.0 [2.0–6.0]
t1/2 (h)^c	1.74 ± 0.69 (40)	1.62 ± 0.67 (41)
λzc (1/h)	0.45 ± 0.15 (34)	0.49 ± 0.17 (35)
MRT^c	3.72 ± 0.76 (20)	4.26 ± 1.01 (24)
AUC_last/AUC_inf^c	0.98 ± 0.03 (3.5)	0.97 ± 0.04 (4.2)
AUC_extrapolated%^d	2.25 [0.21–14.64] (151)	2.68 [0.19–15.99] (153)

^aGeometric mean (percent coefficient of variation [%CV]); ^bmedian [range]; ^carithmetic mean ± standard deviation (%CV); ^dmedian [range] (%CV).

Table 1: Summary of pharmacokinetic parameters of plasma omeprazole following single oral doses of omeprazole 40 mg delayed-release capsule formulation and Losec^® capsule (2 x 20 mg).

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