Bioequivalence and safety evaluation of levetiracetam tablets in healthy volunteers
10.13699/j.cnki.1001-6821.2015.14.017
- VernacularTitle:左乙拉西坦片在中国成年健康志愿者的生物等效性及安全性评价
- Author:
Shu-Min WANG
1
;
Hui ZHOU
;
Shao-Jie GUO
;
Feng WU
;
Si-Yang NI
;
Xiu-Li ZHAO
;
Yun-Xia CHAN
;
Yu-Xian GENG
Author Information
1. 首都医科大学 附属北京同仁医院 国家药物临床试验机构
- Keywords:
levetiracetam;
bioequivalence;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2015;(14):1411-1414
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study pharmacokinetic behaviors of the Chinese healthy volunteers and to evaluate the bioequivalence of two kinds of levetiracetam tablets.Methods Twenty healthy male volunteers were randomly divided into two groups, each group 10 cases, they were orally respectively administrated with single dose of treatment and reference preparations of levetiracetam ( each 0.5 g).The cleaning peri-od was one week.The concentration of levetiracetam in human plasma was measured by LC/MS/MS.Main pharmacokinetic parameters were calculated by using WinNonlin 6.3 software.Results Main pharmaco-kinetic parameters of test and reference preparation were as follow:t1/2 were(8.01 ±1.16), (8.02 ±0.93) h, tmax were (0.61 ±0.41), (0.76 ±0.61 ) h, Cmax were ( 13.65 ±2.63 ), ( 13.15 ±2.30 )μg? mL-1 , AUC0-t were ( 115.84 ±12.75 ) , ( 119.29 ±15.29 )μg? mL-1? h,AUC0-∞ were ( 121.44 ±15.17 ) , ( 124.89 ±16.73 )μg? mL-1? h,respectively.The relative bioavailability of test prepara-tion was ( 97.55 ±7.06 )%.Conclusion Two kinds of levetiracetam tablets are bioequivalent.
