This randomized, six-treatment, six-period, six sequence, single dose, crossover pharmacokinetic study assessed the effect of different types of food on the bioavailability of 500-mg cefaclor extended release tablet in 23 healthy male volunteers. A single dose of cefaclor extended release 500-mg tablet was administered at six occasions: after overnight fasting, after two vegetarian (high-fat and low-fat), two non-vegetarian (high-fat and low-fat) and rice diets. Serial blood samples were collected up to 12 h after dose. Serum cefaclor concentrations were determined by a validated HPLC method. An almost equivalent increase in both Cmax and AUC was observed with both high-fat non-vegetarian and low-fat vegetarian breakfasts. However, when MIC90 values, a pharmacodynamic end-point were compared, the low-fat vegetarian diet fared better than the high-fat non-vegetarian diet. The results obtained favor low-fat vegetarian diet (breakfast) to be taken with cefaclor extended release tablet to achieve maximum benefit in terms of clinical efficacy.

译文

:这项随机,六次治疗,六次治疗,六次治疗,六次治疗,单次剂量,交叉药代动力学研究评估了23种健康男性志愿者中不同类型食物对500 mg头孢克洛缓释片生物利用度的影响。单剂量头孢克洛500毫克头孢克洛缓释片分六次服用:禁食过夜后,两次素食(高脂和低脂),两次非素食(高脂和低脂)和大米饮食后。给药后直至12 h收集系列血样。血清头孢克洛浓度通过有效的HPLC方法测定。高脂非素食早餐和低脂素食早餐的Cmax和AUC均几乎增加。但是,当比较MIC90值(药效学终点)时,低脂素食饮食的表现要好于高脂非素食饮食。获得的结果有利于低脂素食饮食(早餐),与头孢克洛缓释片一起服用可在临床疗效方面获得最大收益。

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