Table 3 The PK of test and reference preparation about CYP2C19 phenotypes.
CYP2C19 gene polymorphisms | AUC0–t (ng h mL−1) | AUC0–∞ | Cmax(ng mL−1) | T1/2 (h) | Tmax (h) | λz (h−1) | CL (L h kg−1) | Vd (L kg−1) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
T | R | T | R | T | R | T | R | T | R | T | R | T | R | T | R | |
EM (N = 12) | 552.90 ± 391.42 | 591.09 ± 401.03 | 563.59 ± 378.58 | 600.82 ± 387.43 | 633.25 ± 295.94 | 690.50 ± 338.19 | 0.74 ± 0.19 | 0.78 ± 0.17 | 0.25 (0.17, 0.75) | 0.25 (0.17, 0.5) | 0.99 ± 0.2 | 0.92 ± 0.19 | 50.95 ± 28.09 | 45.23 ± 23.32 | 35.03 ± 18.45 | 24.68 ± 11.92 |
IM (N = 24) | 1520.14 ± 1437.90 | 1475.31 ± 1356.51 | 1558.7 ± 1495.48 | 1508.26 ± 1402.83 | 1044.21 ± 320.07 | 1060.33 ± 303.17 | 1.13 ± 0.65 | 1.11 ± 0.63 | 0.25 (0.17, 0.5) | 0.25 (0.08, 0.5) | 0.75 ± 0.27 | 0.76 ± 0.26 | 20.4 ± 11.91 | 21.72 ± 11.78 | 25.55 ± 9.06 | 26.78 ± 7.98 |
PM (N = 4) | 4526.56 ± 651.59 | 4913.02 ± 738.77 | 4679.13 ± 627.44 | 5089.02 ± 742.13 | 1650.00 ± 451.66 | 1670.00 ± 530.28 | 2.48 ± 0.24 | 2.46 ± 0.16 | 0.3 (0.25 0.5) | 0.29 (0.17, 1) | 0.28 ± 0.03 | 0.28 ± 0.18 | 4.32 ± 0.54 | 4.28 ± 0.25 | 15.79 ± 3.32 | 15.79 ± 0.74 |
p (EM/IM) | < 0.05 | < 0.05 | < 0.05 | < 0.05 | < 0.001 | 0.002 | 0.049 | 0.08 | 0.96 | 0.67 | 0.01 | 0.06 | 0.04 | 0.5 | < 0.001 | < 0.001 |
p (EM/PM) | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | 0.48 | 0.24 | < 0.001 | < 0.001 | 0.06 | 0.15 | 0.005 | 0.004 |
p (IM/PM/) | < 0.001 | < 0.001 | < 0.001 | < 0.001 | 0.002 | 0.002 | < 0.001 | < 0.001 | 0.41 | 0.14 | 0.002 | 0.001 | 0.045 | 0.009 | 0.01 | 0.007 |