Saffar F, Aiache J M, Andre P
Laboratoire de Biopharmacie, Faculté de Pharmacie, Clermont-Ferrand, France.
Methods Find Exp Clin Pharmacol. 1995 Sep;17(7):483-7.
The effect of food on the bioavailability of the antidiabetic drug metformin (Glucophage, Lipha Laboratories) was investigated in patients at steady-state. Seventeen diabetic patients (5 males and 12 females) treated with a long-term metformin therapy received their morning dose after an overnight fasting or after each of four types of breakfast: low protein, low fat, low carbohydrate or standard. Mean (+/- SD) and median areas under the serum concentration curves (AUC), maximum concentrations (Cmax) and time to reach the Cmax (Tmax) were calculated. Compared to fasting conditions, AUC and Cmax for metformin were bioequivalent after the four types of breakfast except the low fat (high carbohydrate) diet which had results slightly reduced (90% CI = [0.76-0.90]). The intraindividual variability was calculated and found to be lower than the interindividual variability.
在处于稳态的患者中研究了食物对降糖药物二甲双胍(格华止,利发制药实验室)生物利用度的影响。17例接受长期二甲双胍治疗的糖尿病患者(5例男性和12例女性)在空腹过夜后或在四种类型的早餐(低蛋白、低脂、低碳水化合物或标准早餐)后的每一种之后服用其晨剂量。计算血清浓度曲线下的平均(±标准差)和中位数面积(AUC)、最大浓度(Cmax)以及达到Cmax的时间(Tmax)。与空腹状态相比,除低脂(高碳水化合物)饮食导致结果略有降低(90%CI = [0.76 - 0.90])外,四种类型早餐后二甲双胍的AUC和Cmax具有生物等效性。计算了个体内变异性,发现其低于个体间变异性。