Table 3.
Summary of pharmacokinetic parameters of amphotericin B after intravenous (IV) or oral administration of Fungizone® and Ambicelles (n=3)
Parameters | Fungizone® IV | Ambicelles IV | Fungizone® oral | Ambicelles oral |
---|---|---|---|---|
Dose (mg/kg) | 0.8 | 0.8 | 10 | 10 |
AUC0–24 (h·μg/mL) | 2.222±0.318 | 6.746±2.061 | 0.937±0.092 | 0.979±0.080 |
AUC0–72 (h·μg/mL) | 3.556±0.393 | 8.370±2.216 | ||
AUC0→∞ (h·μg/mL) | 3.962±0.320 | 8.642±3.258 | 1.021±0.148 | 1.555±0.150 |
Cmax (μg/mL) | NA | NA | 0.066±0.013 | 0.074±0.009 |
Tmax (h) | NA | NA | 7.00±2.65 | 3.00±1.73 |
T1/2 (h) | 17.54±1.15 | 16.41±2.28 | 5.996±0.50 | 13.93±3.01 |
CL (mL/h/kg) | 0.202±0.018 | 0.092±0.038 | 9.790±1.350 | 6.910±0.660 |
V (mL/kg) | 7.03±2.72 | 2.19±1.22 | 84.70±18.87 | 138.94±32.97 |
BA (%) (IV–oral) | 100 | NA | 2.08 | 3.13 |
BA (%) (IV–IV) | 100 | 218 | NA | NA |
Note: Data shown as mean ± standard deviation unless otherwise stated.
Abbreviations: AUC, area under the concentration time curve; Cmax, maximal plasma concentration; T1/2, half-life; CL, clearance; V, volume of distribution; NA, not applicable; BA, bioavailability.