中国药房2013，Vol.24Issue(10)：907-909,3.DOI:10.6039/j.issn.1001-0408.2013.10.16
左乙拉西坦片在健康人体内的生物等效性研究
Bioequivalence of Levetiracetam Tablets in Healthy Volunteers
摘要
Abstract
OBJECTIVE: To study the bioequivalence of 2 kinds of Levetiracetam tablets in Chinese healthy volunteers. METHODS: In randomized crossover study, 20 healthy male volunteers were given single oral dose of test preparation (domestic) and reference preparation (imported) of Levetiracetam tablet (500 mg). The concentration of levetiracetam in human plasma was measured by HPLC-UV. All statistic analysis was performed by using SPSS 17.0 statistics software. RESULTS: Main pharmacokinetic parameters of test and reference preparation were as follow: Cmax were (17.34 ± 3.45) mg/L and (16.34 ± 3.46) mg/L; tmax were (0.6 ± 0.3) h and (0.6±0.3) h; AUC0-24, were (123.2± 15.7) mg·h/L and (121.5± 18.4) mg·h/L; AUC0-∞ were (129.4± 15.3) mg·h/L and (128.5 ± 17.7) mg·h/L. The relative bioavailability of test preparation was (102.0 ± 7.8)%. CONCLUSIONS: 2 kinds of Levetiracetam tablets are bioequivalent.关键词
左乙拉西坦/生物等效性/高效液相色谱-紫外法Key words
Levetiracetam/ Bioequivalence/ HPLC-UV分类
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何小爱,刘智,朱刚直..左乙拉西坦片在健康人体内的生物等效性研究[J].中国药房,2013,24(10):907-909,3.
