[Translation] A single-center, randomized, open-label, two-period, double-crossover design to evaluate the bioequivalence of a single-dose subcutaneous insulin aspart 30 injection in healthy men
以诺和锐30为参比制剂,以辽宁博鳌生物制药有限公司生产的门冬胰岛素30注射液为受试制剂,通过单中心、随机、开放、双周期、双交叉的高胰岛素-正常血糖葡萄糖钳夹试验,以药代动力学和药效动力学参数评价两种制剂在健康中国男性受试者的生物等效性,及受试制剂和参比制剂在中国健康男性受试者中的安全性。
[Translation] Using NovoRapid 30 as the reference preparation and Insulin Aspart 30 Injection produced by Liaoning Boao Biopharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, two-period, double-crossover hyperinsulinemic-euglycemic glucose clamp study was conducted to evaluate the bioequivalence of the two preparations in healthy Chinese male subjects using pharmacokinetic and pharmacodynamic parameters, as well as the safety of the test and reference preparations in healthy Chinese male subjects.