Table 1 Study design
Group no. | Dose groups | Doses (mg/kg) | Concentrations (mg/mL) | Dose volume (mL/kg) | No. of animals | |
a. Treatment groups for the syngeneic fibrosarcoma tumour efficacy study | ||||||
1 | Placebo | Nil | Nil | 4.5 | 15 | |
2 | SPIL DXR HCl liposome injection | 9.0 | 2.0 | 4.5 | 11 | |
3 | Reference DXR HCl liposome injection | 9.0 | 2.0 | 4.5 | 15 | |
Total number | 41 | |||||
b. Treatment groups for the human mammary carcinoma xenograft efficacy study | ||||||
1 | Placebo | Nil | Nil | 10.0 | 10 | |
2 | SPIL DXR HCl liposome injection | 1.5 | 0.6 | 2.5 | 10 | |
3 | 3.0 | 0.6 | 5.0 | 10 | ||
4 | 6.0 | 0.6 | 10.0 | 10 | ||
5 | Reference DXR HCl liposome injection | 1.5 | 0.6 | 2.5 | 10 | |
6 | 3.0 | 0.6 | 5.0 | 10 | ||
7 | 6.0 | 0.6 | 10.0 | 10 | ||
Total number | 70 | |||||
Group no. | Dose groups | Doses (mg/kg) | Concentrations (mg/mL) | Dose volume (mL/kg) | Time point (hour) | No. of animals per time point |
c. Study groups for the syngeneic fibrosarcoma tumour bioequivalence study | ||||||
1 | SPIL DXR HCl liposome injection | 5 | 1 | 5 | 0.08 | 12 |
0.5 | 12 | |||||
3 | 12 | |||||
5 | 12 | |||||
8 | 12 | |||||
24 | 12 | |||||
48 | 12 | |||||
96 | 12 | |||||
168 | 12 | |||||
240 | 12 | |||||
2 | Reference DXR HCl liposome injection | 5 | 1 | 5 | 0.08 | 12 |
0.5 | 12 | |||||
3 | 12 | |||||
5 | 12 | |||||
8 | 12 | |||||
24 | 12 | |||||
48 | 12 | |||||
96 | 12 | |||||
168 | 12 | |||||
240 | 12 | |||||
Total number | 240 | |||||