| Parameters |
Product |
Fasting study |
Non-fasting study |
Cmax (ng/mL) |
AUC0-t (ng.h/mL) |
AUC0-∞ (ng.h/mL) |
Cmax (ng/mL) |
AUC0-t (ng.h/mL) |
AUC0-∞
(ng.h/mL) |
| Geometric Mean |
Test (A) |
1158.124 |
5417.395 |
5789.848 |
1387.719 |
6285.006 |
6523.251 |
Reference B) |
1227.654 |
5562.313 |
5890.051 |
1409.831 |
6793.396 |
7057.526 |
| Least Square Mean (LSM) |
Test (A) |
1100.218 |
5146.525 |
5500.356 |
1339.339 |
5970.755 |
6197.088 |
Reference(B) |
1166.271 |
5284.197 |
5595.548 |
1318.333 |
6453.726 |
6704.65 |
| LSM Ration A/B % |
|
94.34 |
97.39 |
98.30 |
98.43 |
92.52 |
92.43 |
| 90% Confidence Interval : A/B |
|
|
|
|
|
|
|
| Lower Limit |
|
97.82 |
87.22 |
86.45 |
96.28 |
86.39 |
86.29 |
| Upper Limit |
|
102.01 |
113.34 |
100.78 |
110.16 |
102.15 |
101.42 |
P – value (ANOVA)
Period
Formulation
Sequence |
|
0.7251
0.9077
0.0562 |
0.7701
0.9981
0.0217 |
0.1303
0.7624
0.0142 |
0.4266
0.5238
0.9900 |
0.6594
0.7722
0.4586 |
0.4148
0.8947
0.0567 |
| Intra-subject Variability: (CV%) |
|
14.10 |
16.04 |
14.7 |
18.52 |
17.02 |
16.39 |
| Power (%) |
|
99.99 |
98.73 |
99.46 |
98.96 |
99.54 |
99.69 |
Untransformed Tmax (p-value)
(Wilcoxon signed rank test) |
|
0.9473 |
0.9727 |
Note: A= Test Product and B=Reference Product; CV = Coefficient of Variance |
