Study on the Bioequivalence of Itopride Hydrochloride Tablets in Healthy Subjects

OBJECTIVE To evaluate the bioequivalence of itopride hydrochloride tablets.METHODS The concentration of itopride in plasma was measured by HPLC-MS/MS.Sixty-four healthy subjects (32 on fasting and 32 after meal) were randomly assigned to take a single dose of itopride hydrochloride tablets 50 mg orally as test preparation and reference preparation.The plasma concentrations of itopride hydrochloride tablets were determined at different times and the pharmacokinetic parameters were calculated by Phoenix WinNonlin software.RESULTS Under fasting conditions,the 90% confidence intervals of C_max,AUC_0-t and AUC_0-∞ for the test/reference geometric mean ratio were 89.42%-118.95%,93.25%-117.27%,92.78%-117.33%.Under fed conditions,the 90% confidence intervals of C_max,AUC_0-t and AUC_0-∞ for the test/reference geometric mean ratio were 90.53%-104.83%,96.72%-99.77%,96.76%-99.88%.CONCLUSION The test preparation and reference preparation of itopride hydrochloride tablets are bioequivalent.