TABLE 2.
Parameter | Value in indicated study |
|||
---|---|---|---|---|
This study | Raaflaub and Zeigler (3) | Raaflaub (4) | Soy et al. (6) | |
No. of subjects (age range, yrs) | 8 (19–32) | 6 (22–24) | 8 | 49 (19–55) |
Dose | 100 mg, single dose | 100 mg, single dose | 3.5 mg/kg/12 h, multiple doses | 2.5 mg/kg/12 h, multiple doses |
t1/2 (h) | 12.1 (13.7–11.1) | 11.7 (13–11.1) | 13.75 (15–12) | 36 |
Tmax, h (range) | 3.5 (4–2.7) | 3.5 (4–3) | ||
Cmax (μg · ml−1) | 2.2 (2.8–1.7) | 2.61 (2.6–2.3) | SS max: 12.54 (14–11) SS min: 8.02 (9.6–7.1) | |
AUC0–t (μg · h/ml−1) | 46.4 (56.3–40.5) | |||
AUC0–∞ (μg · h/ml−1) | 48.4 (57.2–40.9) | |||
V/F (liters) | 34.5 (39.7–29.5) | 89.6 | ||
CL/F (liters/h) | 2.07 (2.4–1.7) | 0.56 (0.6–0.5) | 1.73 |
Data are reported as medians and interquartile ranges. Tmax data are shown as medians and ranges. t1/2, elimination half-life; Tmax, observed time to reach the maximum concentration in plasma; Cmax, observed maximum concentration in plasma; AUC0–t, area under the plasma drug concentration-time curve from 0 to the last measurable concentration; AUC0–∞, area under plasma drug concentration-time curve from 0 to infinity; V/F, apparent volume of distribution; CL/F, apparent oral clearance; SS max, steady-state maxima; SS min, steady-state minima.