| 英文摘要 |
The study was to assess the bioequivalence of two cefuroxime axetil tablets. The test product was Cefxin tablet; the reference product was Zinnat tablet. Twelve healthy adult male volunteers participated in the study. Every subject received each formulation according to a completely double-blind randomized cross-over design with a one-week washout period before the second dose. Following oral administration of two cefuroxime axetil tablets, blood samples were drawn thirteen times over a period of ten hours. These samples were analyzed for cefuroxime concentrations using a sensitive and specific high performance liquid chromatography. Statistical assessments were performed, including ANOVA, power analysis and 90% confidence interval of ratio on various pharmacokinetic parameters derived from the plasma drug concentration-time profiles. The results indicated that the AUC0-t, AUC0-inf, peak concentration and mean resident time for the two products were not statistically significant different, i.e., the two products showed no difference in the rate and extent of drug absorption. Namely, there is no statistically significant difference between the bioavailability of Cefxin and Zinnat.
本研究旨在評估兩種cefuroxime axetil錠劑之生體相等性。試驗品為Cefxin錠，參考品為Zinnat錠。十二位健康成年男性自願者，以隨機雙盲交叉之實驗設計方式給予cefuroxime axetil錠，兩次給藥間有一星期的間隔時間。每位受試者口服兩粒cefuroxime axetil錠後，於十小時內抽血十三次，此血液樣本透過高效液相層析儀分析其中cefuroxime之濃度。由藥物血中濃度──時間之數據得到藥物動力學參數後作ANOVA、統計能力分析、90%信賴區間等統計比較。結果顯示兩種cefuroxime axetil錠之AUC0-t，AUC0-inf，尖峰血中濃度及平均滯留時間，在統計學上均沒有顯著之差異；亦即兩種藥品之吸收程度和吸收速率沒有差異。根據以上之結果，可證明Cefxin和Zinnat之生體可用率在統計學上沒有顯著之差異。 |
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