| Parameter |
Ln transformed Data – Baseline adjusted data |
| Geometric Mean |
(T1/R) Ratio
(%) |
90% Confidence Interval |
Intra Subject CV (%) |
Test-1
(T1) |
Reference
(R) |
| Cmax |
6.20 |
2.73 |
227.51 |
146.61-353.03 |
87.49 |
| AUC0®t |
12.35 |
7.64 |
161.53 |
101.53-256.99 |
94.16 |
| AUC0®∞ |
13.14 |
9.78 |
134.42 |
88.86-203.36 |
74.66 |
| ANOVA p-value for Lntransformed Data |
| Parameter |
Cmax |
AUC0®t |
AUC0®∞ |
| Sequence |
0.3177 |
0.5453 |
0.5344 |
| Period |
0.2663 |
0.3906 |
0.7294 |
| Treatment |
<.0001* |
<.0001* |
<.0001* |
|
