[Translation] A randomized, open-label, single-dose, two-period, crossover phase I clinical study on the pharmacokinetics and safety of degludec and insulin aspart injection versus Tresiba®/RYZODEG® in healthy Chinese subjects
主要目的
评估在中国健康成年受试者中单剂量皮下注射吉林惠升生物制药有限公司研制的德谷门冬双胰岛素注射液与诺和诺德公司的诺和佳®/RYZODEG®相比的药代动力学(PK)特征。
次要目的
评估在中国健康成年受试者中单剂量皮下注射吉林惠升生物制药有限公司研制的德谷门冬双胰岛素注射液的安全性。
[Translation] Primary objective
To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous dose of degludec and insulin aspart injection developed by Jilin Huisheng Biopharmaceutical Co., Ltd. compared with Novo Nordisk's Novogard®/RYZODEG® in healthy Chinese adult subjects.
Secondary objective
To evaluate the safety of a single subcutaneous dose of degludec and insulin aspart injection developed by Jilin Huisheng Biopharmaceutical Co., Ltd. in healthy Chinese adult subjects.