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目的评价2种国产盐酸二甲双胍片(口服降糖药)在中国健康人体的生物等效性。方法 20名健康男性受试者随机交叉单剂量口服盐酸二甲双胍片试验药物和对照药物,各1.0 g。用高效液相色谱法测定血浆中盐酸二甲双胍的浓度,用DAS 2.0软件计算药代动力学参数,并对2种药物进行生物等效性评价。结果试验药物和对照药物的主要药代动力学参数如下:Cmax为(2.83±0.53),(2.57±0.57)mg.L-1;Tmax为(1.55±0.39),(1.63±0.36)h;t1/2为(3.70±1.76),(3.36±0.72)h;AUC0-24为(10.20±1.95),(9.71±2.56)mg.h.L-1。AUC0-24、AUC0-∞、Cmax的90%可信区间分别为99.1%～114.6%、99.1%～113.8%和100.6%～110.4%。试验药物相对于对照药物的生物利用度F为(108.3±20.5)%。结论试验药物和对照药物生物等效。
Objective To evaluate the bioequivalence of two domestic metformin hydrochloride tablets (oral hypoglycemic agents) in healthy Chinese. Methods A total of 20 healthy male subjects were randomized to receive oral metformin hydrochloride test drug and control drug, 1.0 g each. The concentration of metformin hydrochloride in plasma was determined by HPLC, the pharmacokinetic parameters were calculated by DAS 2.0 software, and the bioequivalence of the two drugs was evaluated. Results The main pharmacokinetic parameters of the test drug and the control drug were as follows: Cmax was (2.83 ± 0.53), (2.57 ± 0.57) mg.L-1; Tmax was (1.55 ± 0.39), (1.63 ± 0.36) h; t1 / 2 was (3.70 ± 1.76) and (3.36 ± 0.72) h respectively; AUC0-24 was (10.20 ± 1.95) and (9.71 ± 2.56) mg.hL-1, respectively. The 90% confidence intervals of AUC0-24, AUC0-∞ and Cmax were 99.1% -114.6%, 99.1% -113.8% and 100.6% -110.4%, respectively. The bioavailability F of the test drug relative to the control drug was (108.3 ± 20.5)%. Conclusion The test drug and control drug are bioequivalent.