Study on the bioequivalence of memantine hydrochloride tablets in Chinese healthy volunteers

OBJECTIVE To evaluate the bioequivalence of two preparations of memantine hydrochloride in healthy volunteers.METHODS A single oral dose of 10 mg test preparation or reference preparation memantine hydrochloride tablets were given to 20 male healthy volunteers in a randomized crossover study.The concentrations of memantine were determined by HPLC-MS/MS method.The pharmacokinetic parameters and relative bioavailability were calculated by DAS 3.0 software,and then the bioequivalence was judged.RESULTS The main pharmacokinetic parameters of test preparation and reference preparation were as follows: Cmax was(18.1±3.8),(20.3±4.2) ng·mL-1;tmax was(12.7±15.1),(8.8±3.0) h;t1/2 was(60.8±15.5),(61.4±19.2) h;AUC0-t was(1 748.6±338.9),(1 720.2±317.3) ng· h· mL-1,respectively.The 90% CIs for the ratios of AUC0-t、AUC0-∞,Cmax were 89.8%~105.6%,89.7%~106.1%,84.8%~93.9%,respectively.The relative bioavailability of test preparation was(95.5±2.9)%.CONCLUSION The results demonstrated that the two preparations were bioequivalent.