Bioeqivalence and pharmacokinetics of aniracetam capsules in healthy volunteers

Objective To study the bioequivalence of aniracetam capsules 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 4 panisamidobutyric acid(ABA),the main active metabolite of aniracetam in serum was determined by HPLC.The main pharmacokinetic parameters were calculated and the bioequivalence was evaluated with DAS2.0 practical pharmacokinetics program.Results After taking a single oral dose of 600 mg for test and reference,the main pharmacokinetic parameters of the tested and referenced were as follows:t_(1/2) were 0.63±0.25 and 0.86±0.59 h.C_(max)were 14.81±3.26 and 15.84±2.89 mg/L.T_(max) were 0.68±0.25 and(0.60)±0.19 h and AUC_(0～3.5 h) were 20.33±4.58 and 20.86±5.76 mg·h~(-1)·L~(-1) respectively.The relative bioavailability of the tested aniracetam capsule was 101.14%±22.05%.Conclusion The test and reference preparation are bioequivalent and may be prescribed interchangeably.