Single-dose pharmacokinetics of levetiracetam in healthy Chinese male subjects

Aims The main aims of this study were to evaluate the pharmacokinetics of levetiracetam in healthy male Chinese volunteers and to assess the dose proportionality between the 500-mg and 1500-mg single doses. Methods This was a randomized, single-centre, single-dose, two-way crossover study. Twenty-six healthy male Chinese subjects were enrolled. All subjects received a single dose of 500 mg or 1500 mg levetiracetam tablet(s) on the dosing day, and the wash-out period was 7 days. Blood was obtained for a 36-h pharmacokinetic evaluation. Results Following single-dose administration of 500 mg and 1500 mg of levetiracetam, the median t(max) was 0.5 and 0.5 h; t(1/2) was 7.3 +/- 0.8 and 7.3 +/- 0.7 h; C-max was 13.6 +/- 3.2 and 47.1 +/- 12.1 mu g ml(-1); AUC(0-infinity) was 109.3 +/- 14.1 and 340.4 +/- 50.6 mu g h(-1) ml(-1); and AUC(0-t) was 105.7 +/- 13.3 and 329.0 +/- 47.9 mu g h(-1) ml(-1), respectively. Conclusions Both C-max and AUCs were dose-proportional over the range of 500-1500 mg. The pharmacokinetic data obtained in these Chinese subjects were similar to the historical data from a matched group of White subjects.