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題 名 | Relative Bioavailability Study of Norfloxacin Tablets=Norfloxacin錠劑相對生體可用率之研究 |
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作 者 | 宋國峻; 張簡雅青; 沈祐緯; 陳隆旭; 陸重隆; 林瑜瑩; 韓若怡; | 書刊名 | 嘉南學報 |
卷 期 | 23 1997.11[民86.11] |
頁 次 | 頁42-51 |
分類號 | 418.43 |
關鍵詞 | 相對生體可用率; 生體相等性; Norfloxacin; Relative bioavailability; Bioequivalence; |
語 文 | 英文(English) |
英文摘要 | 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。而由藥物血中濃度一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。 our 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 Baccidal are bioequivalent. |
本系統中英文摘要資訊取自各篇刊載內容。