Table 2.
Summary of voriconazole pharmacokinetic parameters by treatment after a single intravenous administration at 200 mg
| SYP-1018 (N=52) |
Vfend® (N=52) |
Geometric mean ratioa (90% CI) |
|
|---|---|---|---|
| Tmax (hr) | 1.50 (1.00–1.58) | 1.52 (1.48–1.58) | NA |
| Cmax (μg/L) | 2,120.7±472.3 | 2,141.8±464.1 | 0.99 (0.93–1.04) |
| AUClast (hr·μg/L) | 7,848.0±3,445.2 | 8,125.4±3,539.1 | 0.97 (0.92–1.01) |
| AUCinf (hr·μg/L) | 9,708.8±6,426.7 | 10,127.5±7,120.4 | 0.97 (0.91–1.02) |
| CL (L/hr) | 27.0±11.3 | 26.2±11.0 | NA |
| t1/2 (hr) | 8.13±5.85 | 8.22±6.52 | NA |
Notes: Values are presented as arithmetic mean ± standard deviation, except for Tmax, which is presented as median (range);
a
SYP-1018 to Vfend®.
Abbreviations: CI, confidence interval; Tmax, time to reach maximum plasma concentration; hr, hours; Cmax, maximum plasma concentration; AUClast, area under the concentration–time curve (AUC) from dosing to the last quantifiable concentration; AUCinf, AUC from dosing to infinity; CL, clearance; t1/2, terminal elimination half-life; NA, not applicable.