Pharmacokinetics and bioequivalence of piracetam tablets in healthy volunteers / 中国临床药理学与治疗学

ABSTRACT

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.