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[Translation] Bioequivalence test of insulin aspart 30 injection
主要目的:以Novo Nordisk A/S公司生产的门冬胰岛素30注射液(诺和锐30)为参比制剂,以辽宁博鳌生物制药有限公司生产的门冬胰岛素30注射液为受试制剂,通过单中心、随机、盲法、双周期、双交叉的正常血糖葡萄糖钳夹试验,以药代动力学和药效动力学参数评价两种制剂在健康中国男性受试者的生物等效性。次要目的:评价受试制剂和参比制剂在中国健康男性受试者中的安全性。
[Translation] Main purpose: Taking insulin aspart 30 injection (Novo Sharp 30) produced by Novo Nordisk A/S company as the reference preparation and insulin aspart 30 injection produced by Liaoning Boao Biopharmaceutical Co., Ltd. as the test preparation, passed A single-center, randomized, blinded, double-period, double-crossover euglycemic clamp trial was conducted to evaluate the bioequivalence of two preparations in healthy Chinese male subjects with pharmacokinetic and pharmacodynamic parameters. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in Chinese healthy male subjects.
[Translation] Human bioequivalence test of insulin glargine injection
通过高胰岛素-正常血糖葡萄糖钳夹试验设计,以药代动力学和药效动力学参数评价受试制剂与参比制剂在健康中国男性受试者的生物等效性。
[Translation] The bioequivalence of the test preparation and the reference preparation in healthy Chinese male subjects was evaluated by pharmacokinetic and pharmacodynamic parameters through a hyperinsulinemic-euglycemic glucose clamp design.
[Translation] Human bioequivalence test of insulin glargine injection
以来得时(甘精胰岛素注射液)为参比制剂,以辽宁博鳌生物制药有限公司生产的甘精胰岛素注射液为受试制剂,通过单中心、随机、盲法、双周期、双交叉的高胰岛素-正常血糖葡萄糖钳夹试验,以药代动力学和药效动力学参数评价两种制剂在健康中国男性受试者的生物等效性、安全性。
[Translation] Since the time (insulin glargine injection) was used as the reference preparation, the insulin glargine injection produced by Liaoning Boao Biopharmaceutical Co., Ltd. was used as the test preparation. Insulin-euglycemic glucose clamp test to evaluate the bioequivalence and safety of the two preparations in healthy Chinese male subjects based on pharmacokinetic and pharmacodynamic parameters.
100 Clinical Results associated with Liaoning Bo'ao Bio-pharmaceutical Co., Ltd.
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