Abstract: AIM: To study the bioequivalence of two ondansetron hydrochloride tablets in Chinese healthy volunteers.METHODS: A randomized crossover study designing was adopted in the study. 20 healthy volunteers were given single oral dose of ondansetron (8 mg). The concentration of ondansetron in plasma was measured by HPLC-MS. All statistic analysis was performed by using SPSS 13.0 statistics software.RESULTS: The pharmacokinetic parameters of the test and reference preparation were as follow: C_max were (33±8) and (32±8) μg/L, t_max were (1.5±0.3) and (1.5±0.4) 　h, AUC_0~24 were (176±67) and (168±58) 　μg·h·L^-1, AUC_0~∞ were (188±70) and (182±63) 　μg·h·L^-1. The relative bioavailability of the test was (103.2±10.0) %.CONCLUSION: The two ondansetron hydrochloride tablets are bioequivalent.

Key words: Ondansetron hydrochloride tablet, Bioequivalence, LC-MS