Objective To study the bioequivalence of posaconazole enteric-coated tablets in healthy volunteers in China.Methods After the subjects took 100 mg of the test or reference preparation orally in the fasting or postprandial state,the blood concentration of posaconazole was detected by LC-MS/MS.The pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.3,and the bioequivalence of the two preparations was evaluated.Results The 90%confidence intervals of the geometric mean ratio of the main pharmacokinetic parameters Cmax,AUC0-t and AUC0-∞of thetwo formulations all fell within 80.00%-125.00%.During the trial,serious adverse events and suspected unexpected adverse events did not occur.Conclusion Under fasting and postprandial conditions,two preparations of posaconazole enteric-coated tablets are bioequivalent in healthy volunteers in China,and the safety of the two preparations is equivalent.
关键词
泊沙康唑肠溶片/空腹和餐后/生物等效性/安全性
Key words
Posaconazole enteric-coated tablets/Fasting and postprandial/Bioequivalence/Safety
维普
万方数据