Bioequivalence of memantine capsules and tablets in human volunteers

AIM To evaluate the bioequivalenee of memantine tablets and capsules.METHODS A randomized,cross over designed trial was conducted in 20 healthy volunteers.The plasma concentrations of memantine were determined by HPLC-MS after a single oral dose of 10 mg tablets of the test and reference preparation,and the pharmacokinetics parameters of memantine were obtained using DAS 2.0 software. RESULTS The pharmacokinetic parameters of the capsule vs tablet drug were as follows:t_(max)(6.1±s 2.4)h and(6.6±2.6)h,c_(max)(13±3)μg·L~(-1)and(12±4)μg·L~(-1),t_(1/2)(63±14)h and(64±12)h,AUC_(0-1) (902±292)μg·h·L~(-1) and (845±256)μg·h·L~(-1).The relative bioavailability of memantine capsules was(110±28)%.The result of statistical analysis showed that there was no significant difference between c_(max),AUC_(0-1) and t_(max) of the two preparations.CONCLUSION The memantine capsules and tablets were bioequivalent.