TABLE 4.
Dose proportionality power model results (with and without data for 0.35-mg/kg dose group)
| Parameter | Day | Adjusted mean slope | 90% CIa
|
|
|---|---|---|---|---|
| Lower | Upper | |||
| Including data for 0.35-mg/kg dose group | ||||
| AUC∞ (ng · h/ml) | 1 | 0.902 | 0.822 | 0.982 |
| AUC24 (ng · h/ml)b | 28 | 0.894 | 0.807 | 0.981 |
| Cmax (ng/ml) | 1 | 0.839 | 0.718 | 0.960 |
| 28 | 0.916 | 0.791 | 1.041 | |
| Removing data for 0.35-mg/kg dose group | ||||
| AUC∞ (ng · h/mL) | 1 | 0.907 | 0.737 | 1.077 |
| AUC24 (ng · h/mL)b | 28 | 0.967 | 0.801 | 1.132 |
| Cmax (ng/ml) | 1 | 0.696 | 0.432 | 0.960 |
| 28 | 1.115 | 0.873 | 1.358 | |
CI, confidence interval.
For the 0.35-mg/kg b.d., 1.5-mg/kg b.d., and 4-mgkg b.d. treatment groups, AUC24 was calculated as AUClast multiplied by 2.