|
Parameter |
Drug Finofibrate |
| Test Product
(A) |
Test Product
(B) |
Reference Product(C) |
| Cmax (ng/mL) |
| Geometric |
11.033±1.855 |
16.310±2.740 |
15.088±1.720 |
| Mean |
6.34 |
8.31 |
11.18 |
| CV% |
28.02 |
31.71 |
15.22 |
| N |
18 |
18 |
18 |
| Tmax (hr) |
| Median |
4.50± 1.156 |
4.50±0.822 |
5.00 ± 1.155 |
| Geometric |
2.91 |
2.75 |
2.50 |
| Mean |
2.56 |
2.74 |
2.48 |
| CV% |
44.11 |
28.81 |
42.65 |
| N |
18 |
18 |
18 |
| AUC0-t (ng.hr/mL) |
|
Geometric |
272.6655±43.766 |
289.1733±55.899 |
256.8569±83.2762 |
| Mean |
120.10 |
134.05 |
153.56 |
| CV% |
34.91 |
38.82 |
27.77 |
| N |
18 |
18 |
18 |
| AUC0-∞ (ng.hr/mL) |
| Geometric |
323.9973±54.6 |
344.9106±64.850 |
305.2371±56.110 |
| Mean |
131.30 |
145.48 |
165.75 |
| CV% |
39.45 |
41.30 |
32.23 |
| N |
18 |
18 |
18 |
| AUC_Extrap ... (%) |
| Geometric |
15.92 ± 4.658 |
13.55±3.535 |
15.85±4.750 |
| Mean |
7.09 |
6.97 |
5.82 |
| CV% |
55.32 |
45.36 |
65.60 |
| N |
18 |
18 |
18 |
| K.e l (hr-1) |
| Geometric |
0.0674±0.011 |
0.0969±0.017 |
0.0688±0.011 |
| Mean |
0.04 |
0.04 |
0.04 |
| CV% |
28.32 |
42.02 |
27.39 |
| N |
18 |
18 |
18 |
| T ½ (hr) |
| Median |
27.8189± 4.731 |
26.3192±5.269 |
28.0859±4.896 |
| Geometric |
19.41 |
18.31 |
17.58 |
| Mean |
18.70 |
17.96 |
17.96 |
| CV% |
24.44 |
28.04 |
26.23 |
| N |
18 |
18 |
18 |
|
