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 |
