Pharmacokinetics and bioequivalence study of cefixime tablets in Chinese healthy volunteers
GUO Wei-yi
FENG Shi-yin
CAI Lin-rui
ZOU Qin
CHEN Zhuo
SU Xu
DU Dan
YU Qin
Abstract：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.
Keywords：cefixime tabletsfastingfedbioequivalencepharmacokinetics
Publication Date：2024-01-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 146-150 )