| A.Pharmacokinetics parameters |
| Parameters (Units) |
Free Doxorubicin (N = 23) |
| Mean ± SD(Un-transformed data) |
| PEGADRIA (T) |
DOXIL® (R) |
| Tmax (h)* |
16.00 (4.0-48.00) |
24.00 (0.950-72.00) |
| Cmax (ng/ml) |
750.5 ± 422.6 |
687.5 ± 388.9 |
| AUC0-t (ng.h/ml) |
83282 ± 36407 |
83253 ± 33591 |
| AUC0-∞ (ng.h/ml) |
91793 ± 37710 |
90447 ± 36597 |
| λz (1 /h) |
0.009 ± 0.004 |
0.010 ± 0.004 |
| t½ (h) |
85.17 ± 27.7 |
80.18 ± 28.09 |
| AUC_% Extrap_Obs (%) |
7.27 ± 5.63 |
6.37 ± 4.59 |
| Vd (L) |
118.19 ± 75.83 |
114.61 ± 75.25 |
| Cl (L/ h) |
0.958 ± 0.476 |
0.988 ± 0.577 |
| *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 |
608.44 |
603.78 |
34.7 |
100.8 |
84.64-119.97 |
| lnAUC0-t |
74011.5 |
75687.3 |
20.7 |
97.8 |
87.96-108.71 |
| lnAUC0-∞ |
85215.8 |
81868.1 |
17.8 |
104.1 |
93.78-115.53 |
| ISCV: Intra subject coefficient of variation; CI: Confidence interval |
