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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2006, Vol. 11 ›› Issue (10): 1144-1147.

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Pharmacokinetics and bioequivalence of piracetam tablets in healthy volunteers

ZHANG Zhi-tao, HUO Qiang1, ZHAO Huai-qing   

  1. College of Pharmacy , Shenyang Pharmaceutical University , Shenyang 110016 , Liaoning , China;
    1Department of Pharmacy Bengbu Medical College , Bengbu 233030 , Anhui , China
  • Received:2006-07-20 Accepted:2006-08-30 Online:2006-10-26 Published:2020-11-05
  • Contact: ZHAO Huai-qing , male , professor , tutor of master ,majoring in pharmacokinet ics of new drugs.Tel:024-23983250  E-mail:zhaohq1955@sina.com
  • About author:ZHANG Zhi-tao , male, postgraduate, majoring in clinical pharmacology and pharmaceutical analysis research.Tel:0552-3175323  E-mail:zhangzhitao2000@126.com

Abstract: AIM: To study the bioequivalence of piracetam tablets in Chinese healthy volunteers.METHODS: 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 bioequivalencewas 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%.CONCLUSION: The test and reference preparations were bioequivalent and may be prescribed interchangeably.

Key words: piracetam, pharmacokinetics, bioequivalence, HPLC

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