Pharmacokinetic
parameters

Ketipinor®

Seroquel®

90% CI of
Test:Reference

Power
(%)

Cmax (ng/ml)

632.27 ± 304.43

638.83 ± 214.49

80.75 - 102.60

92.16

AUC0-last (ng.h/ml)

2625.21 ± 972.14

2511.82 ± 704.21

91.32 - 108.42

96.34

AUC0-∞ (ng.h/ml)

2640.25 ± 979.10

2526.45 ± 704.37

88.47 - 106.77

95.96

Tmax (h)

1.34 ± 1.11

1.01 ± 0.63

 

 

T1/2 (h)

5.15 ± 1.17

4.86 ± 1.35

 

 

CL (L/h)

0.09 ± 0.04

0.09 ± 0.03

 

 

Vd/F (L)

0.70 ± 0.52

0.60 ± 0.25

 

 

AUC extrapolated (%)

0.56 ± 0.59

0.61 ± 0.58

 

 

Table 4: Pharmacokinetic parameters (mean ± SD) and 90% CI of the ratios of the natural Log-transformed of Cmax, AUC0-last and AUC0-∞ between Ketipinor® (test) and Seroquel® (ref.), after a single oral dose of 200-mg of Ketipinor® and Seroquel® in the 24 healthy volunteers.
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