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Table 2 Pharmacokinetic parameters for pantoprazole, rabeprazole, and omeprazole administered under fasting and fed conditions, considering only CYP2C19*1/*1 subjects. Data are expressed as mean ± standard deviation. *p ≤ 0.05 vs. men

From: Effect of food on the pharmacokinetics of omeprazole, pantoprazole and rabeprazole

 

n

AUC0-∞ (ng·h/ml)

Cmax (ng/ml)

Tmax (h)

t1/2 (h)

Vd/F (l/kg)

Cl/F (L/h·kg)

Ke

Pantoprazole (n = 28)

Fast

14

6085.3 ± 2922.6

2539.7 ± 836.3

3.0 ± 0.7

1.2 ± 0.4

0.18 ± 0.03

0.12 ± 0.05

0.64 ± 0.19

  Men

8

4780.9 ± 2471.8

2019.8 ± 492.8

3.0 ± 0.7

1.3 ± 0.5

0.20 ± 0.02

0.14 ± 0.06

0.64 ± 0.23

  Women

6

7824.6 ± 2702.2

3233.0 ± 685.0

2.9 ± 0.8

1.1 ± 0.2

0.16 ± 0.04

0.11 ± 0.04

0.63 ± 0.12

Fed

14

4689.0 ± 2303.3

2660.7 ± 531.2

5.7 ± 1.2

1.2 ± 0.5

0.24 ± 0.05

0.16 ± 0.07

0.67 ± 0.20

  Men

8

4520.4 ± 2518.4

2564.3 ± 581.1

5.3 ± 1.1

1.2 ± 0.6

0.23 ± 0.03

0.15 ± 0.07

0.67 ± 0.25

  Women

6

4913.8 ± 2192.7

2789.3 ± 475.5

6.2 ± 1.1

1.1 ± 0.3

0.25 ± 0.06

0.17 ± 0.08

0.68 ± 0.14

Fed vs. Fast

ratio; 90% CI; p value

74.8; 55.8–100.1

p = 0.1010

103.5; 91.3–117.2

p = 0.6431

192.2; 166.5–221.9

p = 0.001

95.6; 76.7–119.0

p = 0.7262

127.5; 113.2–143.6

p = 0.0018

129.1; 96.7–172.3

p = 0.1439

104.6; 84.0–130.3

p = 0.7262

Rabeprazole (n = 23)

Fast

14

901.2 ± 234.6

536.3 ± 138.2

3.9 ± 0.8

1.3 ± 0.6

0.60 ± 0.11

0.37 ± 0.09

0.63 ± 0.20

  Men

7

870.2 ± 295.6

512.2 ± 146.8

3.9 ± 1.0

1.5 ± 0.7

0.59 ± 0.10

0.33 ± 0.10

0.57 ± 0.25

  Women

7

932.2 ± 172.0

560.4 ± 135.8

3.8 ± 0.7

1.1 ± 0.2

0.61 ± 0.12

0.41 ± 0.07

0.68 ± 0.13

Fed

9

968.9 ± 387.5

606.3 ± 206.8

9.1 ± 3.3

2.0 ± 0.9

0.92 ± 0.34

0.38 ± 0.18

0.45 ± 0.23

  Men

4

999.7 ± 322.7

572.2 ± 215.1

10.3 ± 5.1

2.5 ± 0.7

1.02 ± 0.39

0.30 ± 0.11

0.30 ± 0.11

  Women

5

944.2 ± 469.6*

633.6 ± 220.7

8.2 ± 0.6

1.5 ± 0.9*

0.85 ± 0.32

0.45 ± 0.20*

0.57 ± 0.25*

Fed vs. Fast

104.5; 82.7–131.9

p = 0.7488

111.7; 89.5–139.2

p = 0.3987

228.8; 187.0–278.9

p = 0.0001

152.0; 113.4–203.7

p = 0.023

147.6; 121.6–179.3

p = 0.0025

94.7; 75.1–119.5

p = 0.6913

65.8; 49.1–88.2

p = 0.023

Omeprazole (n = 36)

Fast

15

1709.0 ± 1299.6

859.5 ± 394.9

1.8 ± 0.6

1.0 ± 0.4

0.69 ± 0.38

0.57 ± 0.39

0.81 ± 0.23

  Men

8

1474.9 ± 1403.1

654.1 ± 305.6

2.0 ± 0.7

0.9 ± 0.4

0.68 ± 0.46

0.62 ± 0.44

0.82 ± 0.25

  Women

7

1976.5 ± 1219.8

1094.3 ± 366.6

1.5 ± 0.3

1.0 ± 0.3

0.69 ± 0.46

0.53 ± 0.36

0.79 ± 0.23

Fed

16#

1523.3 ± 1290.5

604.4 ± 362.6

4.7 ± 1.0

1.0 ± 0.4

0.77 ± 0.43

0.62 ± 0.41

0.80 ± 0.36

  Men

10

1409.7 ± 1162.1

582.8 ± 419.1

4.3 ± 1.0

1.0 ± 0.4

0.73 ± 0.38

0.63 ± 0.49

0.84 ± 0.39

  Women

6

1712.7 ± 1250.2

640.4 ± 275.1

5.4 ± 0.4

1.1 ± 0.4

0.84 ± 0.54

0.57 ± 0.29

0.72 ± 0.32

Fed vs. Fast

ratio; 90% CI; p value

88.5; 82.4–95.1

p = 0.0101

64.3; 52.5–78.7

p = 0.0019

278.3; 227.7–340.1

p = 0.0001

104.8; 87.7–125.3

p = 0.6457

118.9; 93.3–151.5

p = 0.2271

115.3; 105.3–126.2

p = 0.0159

95.4; 79.8–114.0

p = 0.6457

  1. #15 of the subjects participated in both fast and fed omeprazole clinical trials