Objective To investigate the bioequivalence of two cefradine capsules in Chinese healthy subjects.Methods This is an open,randomized and two-way crossover clinical trial.In each period,30 healthy subjects received a single dose of either the test or reference cefradine capsule(0.25 g)under fasted and fed conditions.The concentration of cefradine in plasma was determined by liquid chromatoc-tandem mass spectrometry(LC-MS/MS).Pharmacokinetic parameters were calculated with WinNonlin software.Results In the fasting study,the Cmax,AUC0-t and AUC0-∞ of test and reference preparation were 11156.33 and 11747.33 ng/ml,17804.82 and 16902.73 ng/(h·ml),17879.61 and 16984.1 ng/(h·ml),respectively.In the fed study,the Cmax,AUC0-t and AUC0-∞ of test and reference preparation were 5106.33 and 5393.67 ng/ml,16729.83 and 16010.45 ng/(h·ml),17168.00 and 16241.07 ng/(h·ml),respectively.The 90%confidence intervals of the Cmax,AUC0-t and AUC0-∞ for the test and reference preparations were within the range of 80.00%～125.00%.Conclusion The test cefradine capsules and the reference formulation are bioequivalent under both fasting and fed conditions.
关键词
头孢拉定/药代动力学/生物等效性/高效液相色谱串联质谱法
Key words
Cefradine/Pharmacokinetics/Bioequivalence/Liquid chromatography-tandem mass spectrometry
维普
万方数据