Table 1.
Demographic data and pharmacokinetic descriptive statistics of volunteers.
| n | All subjects | Males | Females |
|---|---|---|---|
| 36 | 19 | 17 | |
| Age (years) | 24.25 ± 6.35 | 25.74 ± 8.25 | 22.59 ± 2.48 |
| BMI (kg/m2) | 23.81 ± 2.16 | 24.19 ± 1.96 | 23.39 ± 2.36 |
| Height (m) | 1.67 ± 0.10 | 1.74 ± 0.08a | 1.59 ± 0.06 |
| Weight (kg) | 66.57 ± 11.23 | 73.12 ± 9.58b | 59.25 ± 8.05 |
| Cmax (ng/mL) | 7.04 ± 2.86 | 7.40 ± 3.46 | 6.64 ± 2.01 |
| AUC0-t (ng/mL/h) | 29.87 ± 12.40 | 30.91 ± 15.57 | 28.72 ± 7.79 |
| AUC0-∞ (ng/mL/h) | 36.59 ± 13.66 | 38.38 ± 17.40 | 34.55 ± 7.71 |
| Ke | 0.1923 ± 0.0539 | 0.2056 ± 0.0637 | 0.1774 ± 0.0365 |
| T1/2 (h) | 3.95 ± 1.45 | 3.84 ± 1.83 | 4.07 ± 0.91 |
| Cl (L/h/kg) | 2.32 ± 0.90 | 2.37 ± 1.16 | 2.27 ± 0.51 |
| Vd (L/kg) | 12.92 ± 5.47 | 12.47 ± 6.38 | 13.42 ± 4.38 |
Data shown as mean ± standard deviation. aP = 5.24 × 10−6; bP = 6.97 × 10−5. BMI, body mass index; Cmax, maximum plasma concentration; AUC, area under the plasma concentration-time curve; AUC0-t, AUC from time 0 to the time of last measurement; AUC0-∞, AUC from time 0 extrapolated to infinity; Ke, elimination rate constant in the terminal drug phase; T1/2, half-life drug; Vd, volume of distribution; Cl, total drug clearance.