TABLE 3.
Pharmacokinetic parameters of anidulafungin (parent drug) and drug-derived radioactivity following i.v. infusion of [14C]anidulafungin to healthy male subjects in a phase I clinical studya
| Pharmacokinetic parameter | Mean (% CV) (n = 9)
|
||
|---|---|---|---|
| Anidulafungin (plasma) | Drug-derived radioactivityb
|
||
| Plasma | Whole blood | ||
| Cmax (mg/liter) | 3.63 (15.6) | 3.02 (12.2) | 3.38 (9.07) |
| Tmax (h) | 1.78 (6.65) | 1.78 (6.62) | 1.75 (6.32) |
| AUC0-t (mg·h/liter) | 92.5 (14.4) | 182 (12.3) | 175 (8.11) |
| AUC0-∞ (mg·h/liter) | 98.0 (13.6) | 250 (11.1) | 249 (9.27) |
| t1/2 (h) | 27.7 (8.43) | 119 (11.0) | 139 (9.11) |
| MRT (h) | 35.6 (7.09) | 162 (10.7) | 174 (9.60) |
| Vdss (liters) | 32.6 (17.7) | 57.6 (16.1) | 61.6 (8.94) |
| CL (liters/h) | 0.913 (13.0) | 0.356 (10.9) | 0.356 (9.85) |
a
Abbreviations: Cmax, highest observed concentration; Tmax, time to Cmax; AUC0-t, AUC curve from time zero to the last quantifiable time point; t1/2, terminal-phase half-life; MRT, mean residence time; Vdss, volume of distribution at steady state; CL, total body clearance; CV, coefficient of variation.
b
Radioactivity results are presented as milligram equivalents of anidulafungin.