Khan B A H, Ahmed T, Karim S, Monif T, Saha N, Sharma P L
Department of Pharmaceutical Medicine, Faculty of Pharmacy, Majeedia Hospital, Jamia Hamdard, Hamdard University, Hamdard Nagar, New Delhi, India.
Eur J Drug Metab Pharmacokinet. 2004 Apr-Jun;29(2):125-32. doi: 10.1007/BF03190587.
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.
这项随机、六治疗组、六周期、六序列、单剂量、交叉药代动力学研究评估了不同类型食物对23名健康男性志愿者口服500毫克头孢克洛缓释片生物利用度的影响。在六个不同场合给予单剂量500毫克头孢克洛缓释片：空腹过夜后、两种素食（高脂肪和低脂肪）、两种非素食（高脂肪和低脂肪）饮食以及米饭饮食后。给药后长达12小时采集系列血样。采用经过验证的高效液相色谱法测定血清头孢克洛浓度。高脂肪非素食早餐和低脂肪素食早餐后，Cmax和AUC均出现几乎同等程度的增加。然而，当比较作为药效学终点的MIC90值时，低脂肪素食饮食的效果优于高脂肪非素食饮食。所得结果表明，服用头孢克洛缓释片时，食用低脂肪素食（早餐）在临床疗效方面能实现最大益处。
