| A. Pharmacokinetic parameters |
| Parameters (Units) |
Encapsulated Doxorubicin (N = 23) |
| Mean ± SD(Un-transformed data) |
| PEGADRIA |
DOXIL |
| Tmax (h)* |
2.00 (1.08-8.00) |
2.00 (0.97-8.00) |
| Cmax (ng/ml) |
3817.4±4980.7 |
38307.7±6638.1 |
| AUC0-t (ng.h/ml) |
3282967 ± 1059002 |
3300315 ± 804859 |
| AUC0-∞ (ng.h/ml) |
3573474± 1201583 |
3503506± 969677 |
| λz (1 /h) |
0.011± 0.0043 |
0.012± 0.0060 |
| t½ (h) |
73.06 ± 23.68 |
68.07 ± 29.92 |
| AUC_% Extrap_Obs (%) |
4.74 ± 3.96 |
5.03 ± 4.53 |
| Vd (L) |
2.28 ± 0.71 |
2.12 ± 0.69 |
| Cl (L/ h) |
0.023 ± 0.009 |
0.023 ± 0.008 |
| *Tmax is represented in median value |
| B. Relative bioequivalence |
| Parameters |
Geometric Least Squares Mean |
ISCV (%) |
T/R Ratio(%) |
90% CI |
| PEGADRIA (T) |
DOXIL® (R) |
| lnCmax |
38412.8 |
38591.5 |
7.9 |
99.5 |
95.56-103.68 |
| lnAUC0-t |
3253252.7 |
3364131.8 |
14,7 |
96.7 |
89.65-104.32 |
| lnAUC0-∞ |
3523579.7 |
3569206.4 |
13.1 |
92.09 |
105.83 |
| ISCV: Intra subject coefficient of variation; CI: Confidence interval |
