Pharmacokinetic
Parameters
TestOranor® coated
Tablets 400 mg(ng/mL)
n=26
ReferenceNoroxin®
Tablets 400 mg(ng/mL)
n=26
Cmáx
(ng/mL)
1436.19 ± 521.03
36.28
1310.30
310.66-2506.87
1470.14 ± 477.38
32.47
1397.13
680.01-2625.92
AUC0-24h
(h*ng/mL)
6228.18 ± 2041.06
32.77
5806.15
1666.65-9835.10
6706.32 ± 1853.85
27.64
6454.54
3963.68-9957.76
AUC0-∞
(h*ng/mL)
6658.62 ± 2139.56
32.13
6237.02
1905.93-10608.83
7161.03 ± 1959.37
27.36
6898.09
4237.23-10435.53
tmáx
(h)
1.38 ± 0.49
35.47
1.30
0.50-2.50
1.40 ± 0.66
46.73
1.28
0.50-3.00
Ke
(1/h)
0.1077 ± 0.0115
10.65
0.1071
0.0848-0.1266
0.1073 ± 0.0136
12.67
0.1065
0.0806-0.1490
t½
(h)
6.51 ± 0.73
11.26
6.47
5.48-8.17
6.55 ± 0.80
12.18
6.51
4.65-8.60
AUC Extrapolated
(%)
6.87 ± 2.64
38.47
6.46
3.39-14.69
6.42 ± 1.68
26.24
6.21
4.07-11.13
CV (%)
Geometric mean
Minimum and maximum
Table 1: Pharmacokinetic properties of the test and reference preparations Arithmetic mean ± SD.
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