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Table 4 Summary statistics based on pharmacokinetic data from DXR concentrations in plasma of fibrosarcoma-bearing micea

From: Lipodox® (generic doxorubicin hydrochloride liposome injection): in vivo efficacy and bioequivalence versus Caelyx® (doxorubicin hydrochloride liposome injection) in human mammary carcinoma (MX-1) xenograft and syngeneic fibrosarcoma (WEHI 164) mouse models

Parameter Ln AUC0-t (μg·hr./ml)b Ln AUC0-∞ (μg·hr./ml)b Ln Cmax (μg/mL)b Tmax (hr) T1/2 (hr) Kel (hr−1)
SPIL DXR HCl liposome injection (batch no. LD-72)
 Geometric mean 3002.27 3355.09 120.91 0.13 22.72 0.03
 CV% 11.3 13.7 8.2 102.7 21.7 20.1
Reference DXR HCl liposome injection (lot no. 070382820)
 Geometric mean 3166.07 3444.65 125.64 0.17 27.40 0.03
 CV% 11.3 10.9 7.8 84.8 22.7 20.4
Least-squares means ratio (reference as B:SPIL as A)
 A/B ratio 94.83 97.40 96.24  
 90% confidence interval 87.64–102.60 89.31–106.23 91.12–101.65
Analysis of variance
 Form 0.2593 0.6071 0.2411
 Power 0.9977 0.9935 1.0000
 Interanimal CV% 11.27 12.42 7.81
  1. Abbreviations: AUC area under the curve, C max peak serum concentration, CV% coefficient of variation, DXR doxorubicin, HCl hydrochloride, K el elimination rate constant, SPIL Sun Pharmaceutical Industries Ltd., T 1/2 elimination of half-life, T max time taken to reach the maximum concentration
  2. aThe pharmacokinetic profiles of SPIL and reference DXR HCl liposome injections were evaluated following single intravenous injection in syngeneic fibrosarcoma (WEHI 164)-bearing BALB/c mice. Blood samples were collected at 0.08, 0.50, 3.00, 5.00, 8.00, 24.00, 48.00, 96.00, 168.00 and 240.00 h post injection. Twelve animals were used for a single time point per group. Plasma concentration data were used in the calculation of pharmacokinetic parameters by noncompartmental intravenous-bolus input model (WinNonlin 5.0).
  3. bGeometric least-squares mean values are represented.