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Clinical Trials associated with Semaglutide (China Resources Double-Crane) / Active, not recruitingPhase 3 司美格鲁肽注射液在中国2型糖尿病患者中的有效性和安全性Ⅲ期临床试验
[Translation] Phase III clinical trial on the efficacy and safety of semaglutide injection in Chinese patients with type 2 diabetes
主要目的:
比较司美格鲁肽注射液与诺和泰®在2型糖尿病患者中的有效性。
次要目的:
1)比较司美格鲁肽注射液与诺和泰®在2型糖尿病患者中的安全性;
2)比较司美格鲁肽注射液与诺和泰®在2型糖尿病患者中多次给药后关键PK参数的相似性。
[Translation] Primary objective:
To compare the efficacy of semaglutide injection and Novota® in patients with type 2 diabetes.
Secondary objectives:
1) To compare the safety of semaglutide injection and Novota® in patients with type 2 diabetes;
2) To compare the similarity of key PK parameters of semaglutide injection and Novota® in patients with type 2 diabetes after multiple administration.
[Translation] Comparative study on the pharmacokinetics of semaglutide injection in humans
主要试验目的:研究空腹状态下,单次皮下注射受试制剂司美格鲁肽注射液的药代动力学特征,并与参比制剂司美格鲁肽注射液(诺和泰®)作比对,比较两制剂在健康成年受试者体内的药代动力学特征差异,为该药的申报及临床用药提供参考依据。
次要试验目的:研究空腹状态下,受试制剂司美格鲁肽注射液与参比制剂诺和泰®在健康成年受试者中的安全性。
[Translation] The main purpose of the study: to study the pharmacokinetic characteristics of the test preparation semaglutide injection after a single subcutaneous injection in the fasting state, and to compare it with the reference preparation semaglutide injection (Novota®), to compare the differences in the pharmacokinetic characteristics of the two preparations in healthy adult subjects, and to provide a reference for the application and clinical use of the drug.
Secondary purpose of the study: to study the safety of the test preparation semaglutide injection and the reference preparation Novota® in healthy adult subjects in the fasting state.
100 Clinical Results associated with Semaglutide (China Resources Double-Crane)
100 Translational Medicine associated with Semaglutide (China Resources Double-Crane)
100 Patents (Medical) associated with Semaglutide (China Resources Double-Crane)
100 Deals associated with Semaglutide (China Resources Double-Crane)