Abstract:
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.