Fasting/postprandial bioequivalence of cefdinir granules in healthy Chinese subjects
Objective:To investigate the bioequivalence of a single oral cefdinir reference preparation and test preparation in healthy Chinese adults under fasting and postprandial conditions.Method:A single-center,randomized,open,single-dose,two-agent,two-cycle,double-cross experiment was designed.The test preparation cefdinir granules or reference preparation cefdinir fine granules(50 mg)were randomly cross-administered in the fasting/postprandialstate,and the concentration of cefdinir in plasma was determined by high-performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS).To evaluate the bioequivalence of the two formulations,the main pharmacokinetic parameters were calculated using a non-atrioventricular model using Phoenix WinNonlin 8.3.4 software.Adverse events and serious adverse events were recordedand the safety of the two formulations was evaluated.Results:Twenty-six subjects were enrolled under fasting conditions.The main pharmacokinetic parameters of the test preparation and the reference preparation of oral cefdinir granules were as follows:Cmax were(747.85±205.45)and(740.92±181.86)ng/ml;AUC0-t were(3 881.30±1 033.99)and(3 746.00±910.99)h·ng/ml;AUC0-∞ were(3 908.80±1 047.44)and(3 773.70±922.38)h·ng/ml,respectively.Thirty subjects were enrolled under fed condition.The main pharmacokinetic parameters of the test preparation and the reference preparation of oral cefdinir granules were as follows:Cmax were(329.97±55.30)and(328.43±50.81)ng/ml;AUC0-t were(1 849.40±292.36)and(1 863.30±289.27)h·ng/ml;AUC0-∞ were(1 924.80±322.76)and(1 941.30±303.30)h·ng/ml,respectively.The 90％confidence intervals of Cmax,AUC0-t,and AUC0-∞ geometric mean ratio between the test preparation and reference preparation in fasting and fed conditions were 80.00％～125％.During the research process,a total of 26 adverse events occurred,all of which were mild in severity,and no serious adverse events occurred.Conclusions:The test preparation of cefdinir granules and the reference preparation of cefdinir fine granules are bioequivalent in fasting and postprandial conditions.
万方数据
维普
