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Clinical Trials associated with Insulin Glargine Biosimilar (Dongyangguang)A Single Center, Single-dose, Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between HEC-Glargine and US-Lantus® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers
This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers.
采用葡萄糖钳夹技术在健康男性受试者中比较甘精胰岛素注射液与来得时的PK和PD研究
[Translation] A PK and PD study comparing insulin glargine injection and Lantus in healthy male subjects using glucose clamp technique
主要目的:以赛诺菲安万特(北京)制药有限公司的来得时®为参比制剂,评价单剂量皮下注射宜昌东阳光长江药业股份有限公司生产的甘精胰岛素注射液在中国健康男性受试者中的药效学和药代动力学性质,并评价两种制剂间的生物等效性。 次要目的:评估受试制剂用于中国健康男性受试者时的安全性和耐受性。
[Translation] Primary objective: To evaluate the pharmacodynamic and pharmacokinetic properties of a single subcutaneous dose of insulin glargine injection produced by Yichang East Sunshine Changjiang Pharmaceutical Co., Ltd. in healthy Chinese male subjects, using Lantus® produced by Sanofi-Aventis (Beijing) Pharmaceuticals Co., Ltd. as the reference preparation, and to evaluate the bioequivalence between the two preparations. Secondary objective: To evaluate the safety and tolerability of the test preparation in healthy Chinese male subjects.
多中心、开放、随机、阳性对照试验,评估甘精胰岛素注射液与来得时在2型糖尿病患者中的有效性及安全性
[Translation] A multicenter, open-label, randomized, active-controlled trial to evaluate the efficacy and safety of insulin glargine injection versus Lantus in patients with type 2 diabetes
通过24周非劣效性研究,评价甘精胰岛素注射液与来得时治疗2型糖尿病患者的有效性与安全性
[Translation] A 24-week non-inferiority study to evaluate the efficacy and safety of insulin glargine injection and lantus in the treatment of patients with type 2 diabetes
100 Clinical Results associated with Insulin Glargine Biosimilar (Dongyangguang)
100 Translational Medicine associated with Insulin Glargine Biosimilar (Dongyangguang)
100 Patents (Medical) associated with Insulin Glargine Biosimilar (Dongyangguang)
100 Deals associated with Insulin Glargine Biosimilar (Dongyangguang)