Property

Test Carnotprim®
( n = 25 )

Reference Plasil ®
( n = 25 )

Cmáx (ng/mL)
Arithmetic mean
CV (%)
Geometric mean
Minimum value
Maximum value

36.74 ± 11.61
31.61
35.04
19.97
58.05

37.28 ± 9.47
25.39
36.00
17.83
53.58

AUC0-24 h (h*ng/mL)
Arithmetic mean
CV (%)
Geometric mean
Minimum value
Maximum value

199.29 ± 94.36
47.35
185.05
115.52
531.27

203.85 ± 94.69
46.45
189.98
110.24
570.68

AUC0-∞ (h*ng/mL)
Arithmetic mean
CV (%)
Geometric mean
Minimum value
Maximum value

237.02  ± 106.89
45.10
221.51
131.71
630.39

238.90 ± 106.51
44.59
224.17
129.15
665.80

tmáx (h)
Mean
CV (%)
Geometric mean
Minimum value
Maximum value

0.95 ± 0.25
26.32
0.92
0.5
1.5

0.95 ± 0.38
40.27
0.89
0.5
2.0

Ke (1/h)
Mean
CV (%)
Geometric mean
Minimum value
Maximum value

0.151 ± 0.03
21.15
0.143
0.078
0.196

0.152 ± 0.03
21.88
0.148
0.082
0.252

t½ (h)
Arithmetic mean
CV (%)
Geometric mean
Minimum value
Maximum value

5.00 ± 1.41
28.31
4.84
3.53
8.88

4.81 ± 1.24
25.80
4.68
2.75
8.45

%AUC extrapolated
Arithmetic mean
CV (%)
Geometric mean
Minimum value
Maximum value

16.34 ± 4.55
27.85
15.61
5.93
24.47

15.16 ± 4.16
27.46
14.56
6.88
24.49

Table 2: Pharmacokinetic properties of the test and reference preparations.
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