[Translation] A randomized, open-label, two-period, self-crossover controlled trial to evaluate the pharmacokinetics and safety of degludec and insulin aspart injection versus Novogar® in healthy Chinese subjects
主要目的:
考察德谷门冬双胰岛素注射液的药动学特征,比较中国健康成年受试者单次皮下注射德谷门冬双胰岛素(受试制剂)与原研药“诺和佳®”(参比制剂)的药动学相似性。
次要目的:
1) 评价德谷门冬双胰岛素注射液的安全性;
2) 初步评价德谷门冬双胰岛素注射液的免疫原性。
[Translation] Main purpose:
To investigate the pharmacokinetic characteristics of degludec and insulin aspart injection, and to compare the pharmacokinetic similarity of a single subcutaneous injection of degludec and insulin aspart (test preparation) with the original drug "Novogam®" (reference preparation) in healthy Chinese adult subjects.
Secondary objectives:
1) To evaluate the safety of degludec and insulin aspart injection;
2) To preliminarily evaluate the immunogenicity of degludec and insulin aspart injection.