Qian Zhao1, Ji Jiang, XiaoMing Li, Zhihong Sarah Lu, Pei Hu. 1. Clinical Pharmacology Research Centre, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Abstract
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: * Levetiracetam has been evaluated for epilepsy since 1992. * Pharmacokinetic studies of levetiracetam have been conducted in healthy volunteers, in adults, children and elderly patients with epilepsy, and in patients with renal and hepatic impairment. * Although this antiepileptic has been well studied in Western countries, this paper describes the first such trial of the drug in a Chinese population. WHAT THIS STUDY ADDS: * Information is given on the pharmacokinetics, dose proportionality, safety and tolerability profile of levetiracetam in healthy male Chinese volunteers, and the results are compared with published data obtained in White subjects. * The pharmacokinetics and the pattern of adverse events of levetiracetam in Chinese subjects are similar to the data reported in White 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 microg ml(-1); AUC(0-infinity) was 109.3 +/- 14.1 and 340.4 +/- 50.6 microg h(-1) ml(-1); and AUC(0-t) was 105.7 +/- 13.3 and 329.0 +/- 47.9 microg 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.
RCT Entities:
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: * Levetiracetam has been evaluated for epilepsy since 1992. * Pharmacokinetic studies of levetiracetam have been conducted in healthy volunteers, in adults, children and elderly patients with epilepsy, and in patients with renal and hepatic impairment. * Although this antiepileptic has been well studied in Western countries, this paper describes the first such trial of the drug in a Chinese population. WHAT THIS STUDY ADDS: * Information is given on the pharmacokinetics, dose proportionality, safety and tolerability profile of levetiracetam in healthy male Chinese volunteers, and the results are compared with published data obtained in White subjects. * The pharmacokinetics and the pattern of adverse events of levetiracetam in Chinese subjects are similar to the data reported in White 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 microg ml(-1); AUC(0-infinity) was 109.3 +/- 14.1 and 340.4 +/- 50.6 microg h(-1) ml(-1); and AUC(0-t) was 105.7 +/- 13.3 and 329.0 +/- 47.9 microg 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.
Authors: Roy G Beran; Samuel F Berkovic; Andrew B Black; Gytis Danta; Reinhard Hiersemenzel; Graham J Schapel; Frank J E Vajda Journal: Epilepsy Res Date: 2005-01-06 Impact factor: 3.045
Authors: Tracy A Glauser; John M Pellock; E Martina Bebin; Nathan B Fountain; Frank J Ritter; Christof M Jensen; W Donald Shields Journal: Epilepsia Date: 2002-05 Impact factor: 5.864