阿卡波糖片人体生物等效性研究现状

Current status of bioequivalence of acarbose tablets

阿卡波糖片是治疗Ⅱ型糖尿病的常用药物,因其血药浓度与其临床主要疗效无直接关系,同时作用机制也比较特殊,所以传统的以药动学参数为终点评价指标进行人体生物等效性试验无法评判其等效性,应该以药效动力学指标进行人体生物等效性研究。本文主要介绍了阿卡波糖片人体生物等效性研究的的相关指南及国内外研究现状,为其等效性评价提供参考。

Acarbose is commonly used to treat type Ⅱ diabetes. Because its blood concentration is not directly related to the clinical efficacy,and the mechanism of action is also very special,the traditional bioequivalence trail with pharmacokinetic parameters as endpoints is not available. FDA recommends that bioequivalence should be established by conducting a study with pharmacodynamic endpoints. This review summarizes the guidance and current status of bioequivalence of acarbose,and hopes to provide a reference for its bioequivalence evaluation.