Study on Bioequivalence of Quetiapine Fumarate Tablets in Healthy Vonlunteers

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: C_max(984.9±323.0) μg·L^-1 and (989.6±332.4)μg·L^-1, t_max(0.6±0.3)h and (0.7±0.3)h, t_1/2(4.9±0.7)h and (5.2±1.2)h, AUC_0-36(2 998.7±541.7)μg·L^-1·h and (3 054.1±632.7)μg·L^-1·h, AUC_0-∞(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.