Pharmacokinetics and bioequivalence study of cefixime tablets in Chinese healthy volunteers
Objective:To evaluate the bioequivalence between a single test and reference dose of cefixime tablets in healthy volunteers under fasting and fed conditions.Methods:A randomized,open-label,single-dose,self-crossover design was adopted.UPLC-MS/MS was applied to detect the concentrations of cefixime in the plasma samples of healthy subjects under fasting and fed conditions.Phoenix WinNonlin 8.0 and SAS 9.4 software were used for PK parameters calculation and bioequivalence analysis,respectively.Results:Under fasting condition,34 healthy subjects took 0.2 g test and reference preparation.The ratio of the geometric mean and 90%confidence interval of Cmax,AUC0-t and AUC0-∞ were 105.85%(98.73%,113.48%),103.47(96.34%,111.13%),and 103.23%(96.28%,110.69%),respectively.All the data fell within the equivalent range of 80.0%～125.00%.Under fed condition,34 healthy subjects took 0.2 g test and reference preparation.The ratio of the geometric mean and 90%confidence interval of Cmax,AUC0-t and AUC0-∞ were 101.42%(96.88%,106.16%),99.64%(95.26%,104.23%),and 99.68%(95.54%,104.00%),respectively.All the data fell within the equivalent range of 80.0%～125.00%.Conclusion:The two preparations are bioequivalent under fasting and fed conditions.
NETL
NSTL
万方数据
维普
