吡拉西坦片健康人体药动学和生物等效性研究

目的研究两种吡拉西坦片在健康中国人体的生物等效性.方法20名健康志愿者随机分为试验组和对照组,采用双交叉设计和单剂量口服方式,HPLC法测定血清中吡拉西坦浓度.经DAS2.0统计软件处理,计算主要药代动力学参数,并进行两种片剂的生物等效性评价.结果两种吡拉西坦片剂的t1/2为5.50±1.48、4.29±1.00h,Cmax为21.47±6.27、20.96±5.10mg·L-1,Tmax为O.70±0.46、0.66±0.36 h,AUC0-24h为93.44±16.61、96.67±18.50 mg·h·L-1.受试制剂的相对生物利用度为99.8%±22.7%.结论两种吡拉西坦片剂具有生物等效性.

Pharmacokinetics and bioequivalence of piracetam tablets in healthy volunteers

AIM: To study the bioequivalence of piracetam tablets in Chinese healthy volunteers. METH-ODS: Twenty volunteers were randomly divided into two groups (test and reference), with double cross-over design and single-dose oral administration. The concentration of piracetam in serum was determined by HPLC. The main pharmacokinetic parameters were calculated and the bioequivalence was evaluated with DAS2.0 practical pharmacokinetics program. RESULTS: The pharmacokinetic parameters of piracetam tablets were as follows: t1/2 were 5.50±1.48 and 4.29±1.00 h, Cmax were 21.47± 6.27 and 20.96±5.10 mg·L-1, Tmax were 0.70±0.46 and 0.66± 0.36 h, AUC0-24h were 93.44± 16.61 and 96.67± 18.50 mg·h·L- 1. The relative bioavailability of the test preparation was 99.8%± 22.7%. CONCLU-SION: The test and reference preparations were bioequivalent and may be prescribed interchangeably.