[Translation] A randomized, open-label, two-dose, two-period, two-sequence, single-dose crossover, fasting bioequivalence study of insulin degludec in healthy male subjects
主要目的:通过单中心、随机、开放、双周期、单剂交叉的正常葡萄糖钳夹试验,研究正大天晴药业集团股份有限公司生产的德谷胰岛素与诺和达在健康中国男性受试者空腹状态下的药代动力学和药效学特征,评价皮下注射两种制剂的生物等效性。
次要目的:评价正大天晴药业集团股份有限公司生产的德谷胰岛素与诺和达在健康中国男性受试者安全性。
[Translation] Primary objective: To study the pharmacokinetic and pharmacodynamic characteristics of insulin degludec and Tresiba produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. in healthy Chinese male subjects in the fasting state through a single-center, randomized, open, two-period, single-dose crossover normal glucose clamp trial, and to evaluate the bioequivalence of the two preparations for subcutaneous injection.
Secondary objective: To evaluate the safety of insulin degludec and Tresiba produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. in healthy Chinese male subjects.