Pharmacokinetics and Bioequivalence of Aniracetam Capsules in Healthy Volunteers

Objective To develop an HPLC method for the quantitative determination of aniracetam and to estimate its bioavailability.Methods A single oral administration of test and reference capsules were given(200 mg)to 20 healthy male volunteers according to the randomized crossover design.Plasma concentrations of 4 panisamidobutyric acid(ABA) and the main active metabolite of aniracetam in plasma were determined by HPLC.The pharmacokinetic parameters of test capsules were compared with those of the reference capsules.Results After a single oral administ ration of test and reference capsules,the pharmacokinetic parameters of aniracetam were as the follows:AUC0-t(316.5±113.7) and(313.5±110.2) mg·L-1·min-1(P0.05),cmax(6.49±3.38) and(5.95±2.95)mg·L-1(P0.05),tmax(39.0±16.2) and(35.0±14.3)min(P0.05).The relative bioavailability of the test preparation was(101.5±9.9)%.ConclusionThe two preparations are bioequivalent.