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頁籤選單縮合
題名 | Pharmacokinetic Properties of Tranilast in Chinese People=Tranilast在華人的藥物動力學 |
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作者姓名(中文) | 常敏之; 丁予安; 莊美華; 羅芹懿; 江佩珊; 鮑力恒; | 書刊名 | 藥物食品分析 |
卷期 | 10:3 2002.09[民91.09] |
頁次 | 頁135-138 |
分類號 | 418.1 |
關鍵詞 | 藥物動力學; 生體相等性; 華人; Tranilast; Pharmacokinetics; Bioequivalence; Chinese; |
語文 | 英文(English) |
中文摘要 | 12名健康自願華人男性,以單劑量口服投予兩種Tranilast膠囊製劑(Tranpro®和Rizaben®)之交叉試驗進行其藥物動力學及相對生體可用率之試驗。試驗前及試驗後適當時間之血液檢體收集至24小時,血漿中藥物濃度是以高效能液相層析儀進行分析。口服這二種不同處方膠囊製劑的藥動學參數並無顯著差異,故Tranilast的藥動性質是將其合併起來計算Cmax, Tmax, t1/2及Cl/F分別為42.2±5.92μg/ml, 2.79±1.14 h, 7.58±1.44h及8.12±1.31mL/h/kg。口服Tranpro®和Rizaben®之AUC∞分別為431±97和412±60μg•h/mL,經統計分析之結果顯示二種Tranilast膠囊具生體相等性。 |
英文摘要 | The pharmacokinetics and relative bioavailability of two different formulated tranilast capsules were determined after single dosing in twelve healthy Chinese subjects in a two-way crossover study. Blood samples were obtained from predose until 24 h postdose. Plasma concentration of tranilast was determined by an HPLC method. Since no differences in pharmacokinetic parameters were found between the two distinctive tranilast products (Tranpro_ and Rizaben_), the data were pooled together to characterize the pharmacokinetic property of tranilast. Mean peak plasma concentrations after dosing and the time at which it occurred (Tmax) were 42.2 ± 5.92 μg/mL and 2.79 ± 1.14 h, respectively. The elimination half-life and total body plasma clearance were 7.58 ± 1.44 h and 8.12 ± 1.31 mL/h/kg, respectively. The respective areas under the concentration-time curve from time 0 to infinity for Tranpro_ and Rizaben_ were 431 ± 97 and 412 ± 60 μg•h/mL. The results also indicated that the two tranilast products can be considered as bioequivalent. |
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