[Translation] A randomized, open-label, single-dose, two-dose, three-sequence, three-period, partially repeated clinical study comparing the bioequivalence of recombinant insulin glargine injection and Lantus in healthy Chinese male subjects
主要目的:以赛诺菲安万特(北京)制药有限公司生产的来得时为参比制剂,评价单剂量皮下注射江苏万邦生化医药集团有限责任公司生产的重组甘精胰岛素注射液在中国健康男性受试者中的生物等效性,估算给药后重组甘精胰岛素的药代动力学及药效动力学特征,为正式试验的设计提供一定的参考依据。
次要目的:比较受试制剂和参比制剂用于中国健康男性受试者的安全性。
[Translation] Main purpose: Using Lantus produced by Sanofi-Aventis (Beijing) Pharmaceuticals Co., Ltd. as the reference preparation, evaluate the bioequivalence of a single subcutaneous injection of recombinant insulin glargine injection produced by Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. in healthy Chinese male subjects, estimate the pharmacokinetic and pharmacodynamic characteristics of recombinant insulin glargine after administration, and provide a certain reference basis for the design of formal trials.
Secondary purpose: Compare the safety of the test preparation and the reference preparation for use in healthy Chinese male subjects.