Comparator pH study to evaluate the single-dose pharmacodynamics of dual delayed-release dexlansoprazole 60 mg and delayed-release esomeprazole 40 mg

Figures & data

Figure 1 Mean intragastric pH from 0 to 24 hours postdose after single oral doses of dexlansoprazole modified-release 60 mg (n = 43) and esomeprazole 40 mg (n = 44) delayed-release capsules.

Figure 2 Mean percentage of time with intragastric pH > 4.0 at 0–24 hours, 0–12 hours, and >12–24 hours after single oral doses of dexlansoprazole modified-release 60 mg and esomeprazole 40 mg delayed-release capsules (n = 43). Only subjects who had valid pharmacodynamic parameters estimated for both periods were included in the pharmacodynamic analyses for that parameter.

Notes: *P ≤ 0.05; **P < 0.01; ***P < 0.001.

Figure 3 Mean intragastric pH at 0–24 hours, 0–12 hours, and >12–24 hours after single oral doses of dexlansoprazole modified-release 60 mg and esomeprazole 40 mg delayed-release capsules (n = 43). Only subjects who had valid pharmacodynamic parameters estimated for both periods were included in the pharmacodynamic analyses for that parameter.

Notes: *P ≤ 0.05; **P < 0.01; ***P < 0.001.

Figure 4 Mean plasma concentration-time curves of dexlansoprazole and esomeprazole after single oral doses of dexlansoprazole modified-release 60 mg (n = 43) and esomeprazole 40 mg (n = 44) delayed-release capsules in healthy subjects, linear scale.

Table 1 Summary of plasma pharmacokinetic parameters for dexlansoprazole and esomeprazole after single oral doses of dexlansoprazole MR 60 mg and esomeprazole 40 mg

Pharmacokinetic parameter (unit)	Treatment mean ± SD
	Dexlansoprazole MR 60 mg		Esomeprazole 40 mg
	n	(N = 43)	n	(N = 44)
AUCt (ng · hour/mL)	43	5666 ± 4763.3	44	1877 ± 1265.8
AUC∞ (ng · hour/mL)	32	6841 ± 5787.7	41	1984 ± 1254.3
Cmax (ng/mL)	43	1078 ± 581.5	44	748 ± 444.6
Tmax (hour)^Table Footnotea	43	5.00 (1.0, 12.0)	44	2.00 (1.0, 10.0)
T1/2 (hour)	32	2.83 ± 2.174	41	1.35 ± 0.437
CL/F (L/hour)	32	13.83 ± 9.433	41	28.68 ± 17.364
Vz/F (L)	32	52.70 ± 59.859	41	51.29 ± 31.140

Note:

a T_max values presented are median (minimum, maximum).

Abbreviations: AUC_t, area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration; AUC_∞, area under the plasma concentration-time curve from time 0 to infinity; CL/F, oral clearance; C_max, maximum observed plasma concentration; MR, modified-release; N, number of subjects; n, number of subjects for whom parameter could be calculated; T_1/2, half-life; T_max, time to reach C_max; V_z/F, apparent volume of distribution.