TABLE 4.
Pharmacokinetic parameters of [13C]pantoprazole (mean ± S.D.) in healthy volunteers with CYP2C19*1/*1 (EMs), CYP2C19*1/*2 or CYP2C19*1/*3 (IMs), and CYP2C19*2/*2 (PMs) genotypes after oral administration of a solution consisting of 100 mg of [13C]pantoprazole sodium-sesquihydrate and 2.1 g of sodium bicarbonate Pharmacokinetic parameters are presented as mean ± S.D.
| Parameters | EM (n = 3) | IM (n = 3) | PM (n = 3) | p Valuea |
|---|---|---|---|---|
| Tmax (h) | 0.5 | 0.5 | 0.5 | |
| Half-life (h) | 0.88 ± 0.14* | 1.60 ± 0.61 | 4.23 ± 0.57 | 0.0439 |
| Cmax (μg/ml) | 4.06 ± 1.16 | 4.39 ± 0.61 | 4.29 ± 1.88 | 0.88 |
| AUC0—120 (h/μg/ml) | 4.99 ± 1.08* | 9.96 ± 3.43 | 21.19 ± 4.25 | 0.0439 |
| AUC0—∞ (h/μg/ml) | 5.09 ± 1.08* | 10.35 ± 3.69 | 24.94 ± 4.08 | 0.0439 |
| Vz/F (liters) | 26.20 ± 8.35 | 22.20 ± 1.48 | 25.10 ± 7.35 | 0.88 |
| Cl (ml/h/kg) | 326.9 ± 97.00* | 159.30 ± 52.00 | 67.78 ± 7.60 | 0.0439 |
AUC, area under the concentration versus time curve, 0 to 120 min or 0 to infinity; Vz/F, apparent volume of distribution; Cl, apparent oral clearance corrected for body weight
*
p < 0.05, PM versus EM
a
Comparison between the three genotypes was compared by Kruskal-Wallis statistic with post-hoc analysis using Dunn's Multiple Comparison Test