Bioequivalence of rabeprazole sodium enteric-coated tablets in healthy subjects
OBJECTIVE To explore the bioequivalence of rabeprazole sodium enteric-coated and reference tablets in healthy subjects under fasting and postprandial conditions.METHODS For 26 healthy volunteers for fasting and postprandial tests,10 mg of test preparation or reference preparation was taken orally respectively.The concentration of rabeprazole in human plasma was determined by UPLC-MS/MS.The pharmacokinetic(PK)parameters of rabeprazole were calculated by non-atrioventricular model(NCA module)of Phoenix WinNonlin 8.2 statistical software.Bioequivalence was evaluated.RESULTS The values of 90％CI of Cmax,AUC0-t and AUC0-∞ geometric mean ratio of fasting test preparation and reference preparation rabeprazole were 85.32％-124.01％,93.76％-111.61％and 93.89％-110.21％.And 90％CI of Cmax,AUC0-t and AUC0-∞ geometric mean ratio of test and reference preparations in postprandial test were 86.73％-114.09％,92.33％-110.62％and 98.74％-110.57％.Under fasting and postprandial conditions,90％CI of geometric mean ratio of PK parameters between test preparations and reference preparations were in the range of 80％-125％.CONCLUSION Test and reference preparations of rabeprazole sodium enteric-coated tablets are bioequivalent under fasting and postprandial conditions.
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