盐酸二甲双胍片人体相对生物利用度研究

Study on Relative Bioavailability of Metformin Hydrochloride Table in Human

目的考察盐酸二甲双胍片的人体相对生物利用度。方法22名男性健康受试者,采用单剂量、随机、交叉对照试验设计,空腹口服盐酸二甲双胍片试验和参比制剂各750mg后,采用HPLC法检测血浆中二甲双胍经时过程的血药浓度,计算其药动学参数和相对生物利用度。结果盐酸二甲双胍试验制剂相对于参比制剂的生物利用度为（95.7±28.9）%。主要药动学参数的方差分析和双单侧t检验结果表明,试验制剂和参比制剂AUC0-t,Cmax无显著性差异（P〉0.05）,盐酸二甲双胍试验制剂的AUC0-t,Cmax的90%的置信区间分别为84.1%-101.5%,76.0%-97.6%。结论盐酸二甲双胍片试验和参比制剂具有生物等效性。

OBJECTIVE To determine the relative bioavailability of Metformin Hydrochloride table in healthy male volunteers. METHODS In a randomized two-period cross-over study, a single oral dose of 750mg Mefformin Hydrochloride table （ tested and referenced preparation） were given to 22 healthy male volunteers. The plasma concentrations of Mefformin Hydrochloride were determined by HPLC method. The pharmacokinetic parameters of the two preparations and the relative bioavailability of Metformin Hydrochloride were calculated with statistical analysis. RESULTS The relative bioavailability of Mefformin Hydrochloride in test were （95.7 ± 28. 9） %. There were no significant difference with the pharmacokinetic parameters between tested and referenced preparation （ P 〉 0.05）. The 90% confidence interval of AUC0-1 were 84. 1% - 101.5%, Cmax were76.0% - 97.6%. CONCLUSION The two preparations were bioequivalent.