盐酸二甲双胍片生物等效性研究

Study on Bioequivalence of Domestic Metformin Hydrochloride Tablets

目的;评价贝氏和博莱盐酸二甲双胍片生物等效性。方法:将20名健康男性志愿者随机分为两组,分别交叉口服两种盐酸二甲双胍片剂,用高效液相色谱法测定血清中药物浓度;用3p97软件计算药代动力学参数;用方差分析和单双侧t检验及（1-2α）置信区间法分析两种盐酸二甲双胍片剂是否等效。结果:分别单剂口服1000mg贝氏或博莱盐酸二甲双孤片剂的Tmax为（2.42±1.03）h和（2.50±1.08）h;Cmax分别为（2.22±0.60）μg/ml和（2.12±0.47）μg/ml;AUC0-24分别为（16.69±5.70）mg/（h·L）和（16.98±6.38）mg/（h·L）。经3种方法的统计分析,两者无显著性差异（P>0.05）。结论:贝氏盐酸二甲双胍片与博莱盐酸二甲双胍片的相对生物利用度为（98.29±11.98）％,两种盐酸二甲双胍片剂具有生物等效性。

OBJECTIVE: To study the bioequivalence of Bei Shi metformin hydrochloride(METBS) and Bo Lai metformin hyddrochloride tablets(METBL) in healthy volunteers.METHODS: A single oral dose of 1 OOOmg METBS and METBL were given to 20 healthy volunteers in an open randomized crossover study.Drug concentrations in serum were determined by HPLC.The pharmacokinetic parameters were calculated and analysed by 3p97 program with a statistic analysis of ANOVA, two-one-side t - test and confidence zone of (la-2a)% .RESULTS: The Tmax, Cmax and AUC(10-24) of METBS tables and METBL tables were (2.42 + 1.03) h and (2.50+1.08) h, (2.22+0.69) ug/ml and (2.1210.47) ug/ml, (16.491 5.70) mg/ (h . L) and (16.98 + 6.38) mg/ (h . L), respectively.There were no significant differences between the two formulations in the Tmax, Cmax and AUC (0-24).CONCLUSION: The mean relative bioavailability of METBS tables was(98.29 + 11.98) % compared with METBL tables.The RESULTS: suggest that two products are bioequivalent.