Table 4 The PK of test and reference preparation in males (N = 24) and females (N = 16) healthy volunteers.

From: Pharmacokinetics and bioequivalence evaluation of omeprazole and sodium bicarbonate dry suspensions in healthy Chinese volunteers

Parameter

Test preparation

Reference preparation

Male

Female

p

Male

Female

p

Cmax (ng mL−1)

948.92 ± 356.95

1030.38 ± 533.83

0.57

990.58 ± 387.56

1040.00 ± 501.05

0.73

Tmax (h)

0.25 (0.17, 0.75)

0.25 (0.17, 0.5)

0.79

0.25 (0.17, 1)

0.25 (0.08, 0.5)

0.98

AUC0–t (ng h mL−1)

1530.06 ± 1463.91

1531.43 ± 1800.01

0.99

1580.36 ± 1537.25

1514.00 ± 1784.04

0.90

AUC0–∞ (ng h mL−1)

1574.08 ± 1525.61

1569.40 ± 1855.29

0.99

1623.89 ± 1602.28

1549.42 ± 1834.64

0.89

T1/2 (h)

1.22 ± 0.75

1.03 ± 0.66

0.42

1.21 ± 0.72

1.05 ± 0.62

0.46

λz (h−1)

0.72 ± 0.29

0.85 ± 0.33

0.21

0.73 ± 0.3

0.8 ± 0.27

0.45

  1. Cmax maximum blood concentration, Tmax time to maximum blood concentration, AUC0–t AUC from time 0 (baseline) to time t, AUC0–∞ AUC from zero to infinity, T1/2 elimination half-life, λz apparent end elimination rate constant. Data was presented in mean ± standard deviation. p > 0.05, not significant.
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