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. 2020 Jan 6;38(5):1390–1399. doi: 10.1007/s10637-019-00888-z

Table 5.

Mean pharmacokinetic parameters of S-1 analytes on day 42 following repeated twice daily oral administration of S-1 for two weeks

S-1 analyte
5-FU CDHP Tegafur Oteracil
Aflibercept dose level
Mean ± SD 2 mg/kg 4 mg/kga 2 mg/kg 4 mg/kga 2 mg/kg 4 mg/kga 2 mg/kg 4 mg/kga
Number of patients 7 1 7 1 7 1 7 1
Cmax, ng/mL 130 ± 35.0 104 367 ± 138 266 4730 ± 1840 4670 53.5 ± 38.7 29.5
Tmaxb, h

2.00

(1.97–2.05)

3.95

1.05

(0.97–2.05)

1.97

1.05

(0.92–2.05)

1.97

1.97

(0.97–2.05)

3.95
AUCτ, ng·h/mL 912 ± 174c 654 1650 ± 540e 1320 41,600 ± 19,500 47,100 306 ± 269g 226
AUClast, ng·h/mL 788c ± 370 817 1820e ± 825 1730 91,400 ± 52,600 113,000 378g ± 390 466
t1/2z, h 3.66 ± 0.0225d 3.87 3.63 ± 1.13f 9.2 15.7 ± 4.26 19.6 5.72 ± 3.48h 19.6

CDHP, gimeracil; 5-FU, 5-fluorouracil; SD, standard deviation. PK parameters reported are: AUClast area under the concentration versus time curve (AUC) from time 0 to the real time tlast; AUCτ, AUC from time 0 to the end of the dosing period; Cmax, maximum drug concentration observed; t1/2z, terminal half-life; Tmax, first time to reach Cmax

an = 1, individual values listed

bMedian (range)

cn = 3, 4 patients were not included in the calculation of summary statistics

dn = 2, 5 patients were not included in the calculation of summary statistics

en = 6, 1 patient was not included in the calculation of summary statistics

fn = 4, 3 patients were not included in the calculation of summary statistics

gn = 6, 1 patient was not included in the calculation of summary statistics

hn = 4, 3 patients were not included in the calculation of summary statistics

Profile of 1 patient was excluded for 5-FU, CDHP, tegafur and oteracil