TABLE 1.
Pharmacokinetic parameters of Fungizone and GenericAmB in rabbits with invasive pulmonary aspergillosisa
| Parameter | Fungizone0.5 | GenericAmB0.5 | P value | Fungizone1.0 | GenericAmB1.0 | P value |
|---|---|---|---|---|---|---|
| Cmax (μg/ml) | 14.18 ± 1.71 | 14.62 ± 1.15 | 0.5358 | 21.06 ± 3.06 | 32.55 ± 6.69 | 0.2667 |
| Cmin (μg/ml) | 1.52 ± 0.16 | 1.49 ± 0.06 | 0.9551 | 1.84 ± 0.30 | 2.48 ± 0.16 | 0.0667 |
| AUC0-24 (μg/ml · h) | 56.10 ± 4.39 | 59.34 ± 1.39 | 0.1893 | 73.08 ± 2.38 | 94.36 ± 4.99 | 0.0667 |
| AUC0-∞/dose | 0.09 ± 0.01 | 0.09 ± 0.004 | 0.9551 | 0.07 ± 0.01 | 0.07 ± 0.01 | 0.3833 |
| Vrss (ml/kg) | 150.20 ± 9.25 | 139.90 ± 6.40 | 0.4634 | 229.64 ± 13.02 | 180.56 ± 8.53 | 0.0667 |
| CL (ml/h/kg) | 5.18 ± 0.56 | 4.90 ± 0.19 | 0.5358 | 7.89 ± 1.43 | 6.06 ± 0.49 | 0.1167 |
| t1/2 (h) | 21.77 ± 2.62 | 20.10 ± 1.62 | 0.8665 | 21.70 ± 4.22 | 21.08 ± 1.18 | 0.5167 |
a
All values are expressed as the mean ± the standard error of the mean. Cmin, concentration at 24 h after dosing; AUC0-∞/dose, dose-normalized area under the plasma concentration-versus-time curve from time zero to infinity.