[Translation] A randomized, open-label, two-period, self-crossover controlled trial to evaluate the pharmacokinetics and safety of insulin degludec liraglutide injection and NovoX® in healthy Chinese subjects under fasting conditions
主要目的为考察德谷胰岛素利拉鲁肽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胰岛素利拉鲁肽(受试制剂)与原研药“诺和益®”(参比制剂)的药动学相似性。次要目的为评价德谷胰岛素利拉鲁肽注射液的安全性和初步评价免疫原性。
[Translation] The primary objective is to investigate the pharmacokinetic characteristics of degludec insulin liraglutide injection and to compare the pharmacokinetic similarity of a single subcutaneous injection of degludec insulin liraglutide (test preparation) with the original drug "NovoElix®" (reference preparation) in healthy Chinese adult subjects. The secondary objective is to evaluate the safety of degludec insulin liraglutide injection and preliminarily evaluate its immunogenicity.