Study on Bioequivalence of Quetiapine Fumarate Tablets in Healthy Vonlunteers
Wen Yu-guan · The Chinese Journal of Modern Applied Pharmacy · 2013
OBJECTIVE To study the bioequivalence of quetiapine fumarate in Chinese healthy volunteers.METHODS 200 mg test preparation and reference preparation were given to 20 male healthy vonlunteers in randomized two-way crossover design for the pharmacokinetic and relative bioavailability study.Plasma concentrations of quetiapine were determined by HPLC-MS/MS.RESULTS The primary pharmacokinetic parameters of two preparations were: Cmax(984.9±323.0) μg.L 1and(989.6±332.4)μg.L 1,tmax(0.6±0.3)h and(0.7±0.3)h,t1/2(4.9±0.7)h and(5.2±1.2)h,AUC0-36(2 998.7±541.7)μg.L 1.h and(3 054.1±632.7)μg.L 1.h,AUC0-∞(3 013.0±542.3)μg.L 1.h and(3071.7±630.4)μg.L 1.h respectively.The results of statistical analysis demonstrated the bioequivalence of two preparations,and the relative mean bioavailability of test preparation were(99.1±8.9)%.CONCLUSION The two preparations are bioequivalent.