随机、开放、平行对照的比较利拉鲁肽注射液和诺和力治疗2型糖尿病患者的有效性和安全性的III期临床研究
[Translation] A randomized, open-label, parallel-controlled phase III clinical study comparing the efficacy and safety of liraglutide injection and Victoza in the treatment of patients with type 2 diabetes
主要目的:评价由广东东阳光药业有限公司生产的利拉鲁肽注射液(RD12014)与原研药利拉鲁肽注射液(诺和力)在2型糖尿病患者中有效性是否具有相似性。 次要目的:评价由广东东阳光药业有限公司生产的利拉鲁肽注射液(RD12014)与原研药利拉鲁肽注射液(诺和力)在2型糖尿病患者中安全性、免疫原性及药代动力学是否具有相似性。
[Translation] Primary objective: To evaluate whether the effectiveness of liraglutide injection (RD12014) produced by Guangdong East Sunshine Pharmaceutical Co., Ltd. and the original drug liraglutide injection (Vinoli) are similar in patients with type 2 diabetes. Secondary objective: To evaluate whether the safety, immunogenicity and pharmacokinetics of liraglutide injection (RD12014) produced by Guangdong East Sunshine Pharmaceutical Co., Ltd. and the original drug liraglutide injection (Vinoli) are similar in patients with type 2 diabetes.
一项评价利拉鲁肽注射液(RD12014)与诺和力的随机、开放、两序列、两周期交叉的药代动力学比对试验
[Translation] A randomized, open-label, two-sequence, two-period crossover pharmacokinetic comparison study of liraglutide injection (RD12014) and Victoza
主要目的:以诺和诺德制药有限公司的利拉鲁肽注射液(诺和力)为对照药,评价单剂量皮下注射利拉鲁肽注射液(RD12014)在健康受试者中的药代动力学性质,并比较两种药物药代动力学的相似性。 次要目的:评价试验药利拉鲁肽注射液(RD12014)和对照药利拉鲁肽注射液(诺和力)在健康受试者中安全性和免疫原性的相似性。
[Translation] Primary objective: To evaluate the pharmacokinetic properties of a single subcutaneous dose of liraglutide injection (RD12014) in healthy subjects, using Novo Nordisk's liraglutide injection (Vinoli) as the control drug, and to compare the pharmacokinetic similarity of the two drugs. Secondary objective: To evaluate the similarity of safety and immunogenicity between the experimental drug liraglutide injection (RD12014) and the control drug liraglutide injection (Vinoli) in healthy subjects.
100 Clinical Results associated with Guangdong HEC Bio&Pharm Co., Ltd.
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