The project is to study the bloequivalence of two norfloxacin tablets. The test product was Noraxin tablet (200 mg norfloxacin per tablet); the reference product was Baccidal tahlet (200 mg norfloxacin per tablet). Ten healthy adult male volunteers involved in the study. Every subject received each formulation according to a completely double-blind randomized cross-over design with more than one week wash out period between each dose. Following oral administration of 400mg of the drug (two tablets per subject), blood samples were drawn fourteen times over a period of twenty four hours. These samples were analyzed for norfloxacin concentrations using a sensitive and specific high performance liquid chromatography. Statistical assessments on various Pharmacokinetic parameters derived from the plasma drug concentration-time profiles were used to determine the bioequivalence of these two formulations. By using the ANOVA, power analysis,90% confidence interval and two one sided tests, it is concluded that Noraxin and Baccldal are bioequivalent. 本計畫旨在評估兩種norfloxacin錠劑之生體相等性。試驗品為Noraxin錠(每錠含norfloxacin 200毫克)，參考品為Baccidal錠(每錠含norfloxacin 200毫克)。十位健康成年男性自願者，以隨機雙盲交叉設計的方式投予兩種norfloxacin錠，兩次給藥間至少有一星期的洗出時間。每位受試者口服400毫克norfloxacin(兩粒norfloxacin錠)後，於二十四小時內抽血十四次，此血液樣本乃用高效液相層析儀分析其中norfloxacin之濃度。而由藥物血中濃度 — 時間曲線所得之各個藥物動力學參數則加以統計分析以評估兩種製劑之生體相等性。經由ANOVA、冪次分析、90%信賴區間以及兩個單邊試驗結果顯示Noraxin和Baccidal是具生體相等性的。
