Table 1.
Pharmacokinetic parameters of levetiracetam after a single-dose administration of a 500-mg oral tablet or a 1500-mg oral tablet (3 × 500-mg tablets) in 26 healthy male Chinese subjects
| Parameters | Levetiracetam 500-mg tablet* | Levetiracetam 1500-mg tablet* | CV (%)† | Geometric mean ratio, % (90% CI)‡(dose adjusted) |
|---|---|---|---|---|
| Cmax (µg ml−1) | 13.6 ± 3.2 | 47.1 ± 12.1 | 23.2 | 114.8 (104.0, 125.7) |
| tmax (h) | 0.5 (0.25–2.0) | 0.5 (0.25–1.25) | NA | NA |
| AUC0–t (µg h−1 ml−1) | 105.7 ± 13.3 | 329.0 ± 47.9 | 6.6 | 103.6 (100.5, 106.7) |
| AUC0–∞ (µg h−1 ml−1) | 109.3 ± 14.1 | 340.4 ± 50.6 | 6.6 | 103.6 (100.5, 106.7) |
| t1/2 (h) | 7.3 ± 0.8 | 7.3 ± 0.7 | NA | NA |
| CL/F (l h−1) | 4.7 ± 0.6 | 4.5 ± 0.6 | NA | NA |
| Vz/F (l) | 48.5 ± 6.8 | 47.4 ± 7.0 | NA | NA |
*
Values are arithmetic mean ± SD except for tmax, where values are median (range).
†
Intra-individual CV (%).
‡
Point estimate and 90% CI for the adjusted 1500-mg/500-mg geometric least squares mean ratio (%), derived from anova for continuous parameters.
NA, Not applicable.