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藥物食品分析 MEDLINESCIEScopus

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篇名 Pharmacokinetic Behavior of Ketoconazole in Adult Chinese Males
卷期 5:3
並列篇名 Ketoconazole在中國人體內的藥物動力學特性
作者 許興智陳素容
頁次 193-197
關鍵字 KetoconazolePharmacokineticsChinese藥物動力學中國人MEDLINEScopusSCIE
出刊日期 199709

中文摘要

口服投與含400mg之ketoconazole錠於十四名健康男性獲得如次的藥物動力學參數:AUC∞  (51.4 ± 17.9 mg.h/l, mean ± SD), Cmax(10.3 ± 2.8 mg/l), Tmax(1.5 ± 0.3 h), MRT(4.1±0.7 h), VRT (30.9 ±11.2 h2), CI/F/BW (0.138 ± 0.063 l/h/kg) 和 k* (末端相斜率, 0.33 ± 0.09h-1)。倘若將十四名受試者之血漿中濃度使用傳統的一室體模式加以歸納,吸收速率常數為0.236 ± 0.136 h-1,而消失速率常數為0.172 ± 0.041 h-1。白種人和中國人間之CL/F, k*, Cmax和AUC∞並無顯著差異。唯中國人的Tmax(1.5 ± 0.3 h)遠比白種人(2.6 ± 1.2 h, p<0.01)為短,顯示吸收速率明顯地較快速。

英文摘要

The pharmacokinetic behavior of ketoconazole (Nizoral-Janssen) in Chinese adults was studied in 14 male volunteers. The pharmacokinetic parameters of ketoconazole obtained after oral administration of 400 mg (two tables) were AUC (51.4 ± 17.9 mg.h/l, mean ± SD), Cmax(10.3 ± 2.8mg/l), Tmax(1.5 ± 1.3 h), MRT (4.1±0.7 h), VRT (30.9 ±11.2 h2), CI/F/BW (0.138 ± 0.063 l/h/kg) andk* (slope of terminal phase, 0.33 ± 0.09 h-1). When the plasma concentration data of 14 subjects were fitted to a conventional one-compartment body model, then the first order absorption rate constant was 0.236 ± 0.136 h-1, and the elimination rate constant was 0.172 ± 0.041 h-1. No statistical difference was observed for the parameters CL/F, k*, Cmax and AUC between Caucasians in apublished study and Chinese in this study (p>0.1). However, the Tmax in Chinese (1.5 ± 0.3 h) was significantly shorter than that in Caucasians (2.6 ± 1.2 h, p<0.01).

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