[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover bioequivalence study of insulin aspart injection in healthy Chinese subjects

主要目的：采用正葡萄糖钳夹技术，在健康成年受试者中评价北京双鹭药业股份有限公司研制的门冬胰岛素注射液（受试制剂，T）与诺和诺德（中国）制药有限公司生产的门冬胰岛素注射液（诺和锐®，参比制剂，R）单剂量皮下注射药效学和药代动力学性质及两种制剂间的生物等效性。次要目的：评价门冬胰岛素注射液在健康成年受试者中的安全性。

[Translation]

Primary objective: To evaluate the pharmacodynamic and pharmacokinetic properties of insulin aspart injection (test preparation, T) developed by Beijing Shuanglu Pharmaceutical Co., Ltd. and insulin aspart injection (NovoRapid®, reference preparation, R) produced by Novo Nordisk (China) Pharmaceutical Co., Ltd. after single-dose subcutaneous injection in healthy adult subjects using the euglycemic clamp technique, and the bioequivalence between the two preparations. Secondary objective: To evaluate the safety of insulin aspart injection in healthy adult subjects.

Start Date21 Apr 2021

Sponsor / Collaborator

Beijing SL Pharmaceutical Co., Ltd.

CTR20200976

/ CompletedPhase 1

门冬胰岛素注射液在中国健康受试者中的随机、开放、单剂量、两制剂、两周期、两序列、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-cycle, two-sequence, double-crossover bioequivalence study of insulin aspart injection in healthy Chinese subjects

主要目的：采用正葡萄糖钳夹技术，在健康成年受试者中评价北京双鹭药业股份有限公司研制的门冬胰岛素注射液（受试制剂，T）与诺和诺德公司研制生产的门冬胰岛素注射液（诺和锐®，参比制剂，R）单剂量皮下注射药效学和药代动力学性质及两种制剂间的生物等效性。次要目的：评价门冬胰岛素注射液在健康成年受试者中的安全性。

[Translation]

Primary objective: To evaluate the pharmacodynamic and pharmacokinetic properties of insulin aspart injection (test preparation, T) developed by Beijing Shuanglu Pharmaceutical Co., Ltd. and insulin aspart injection (NovoRapid®, reference preparation, R) developed and produced by Novo Nordisk after single-dose subcutaneous injection in healthy adult subjects using the euglycemic clamp technique, and the bioequivalence between the two preparations. Secondary objective: To evaluate the safety of insulin aspart injection in healthy adult subjects.

Start Date09 May 2020

Sponsor / Collaborator

Beijing SL Pharmaceutical Co., Ltd.

CTR20192181

/ CompletedNot Applicable

门冬胰岛素注射液在中国健康受试者中的随机开放单剂量两制剂两周期两序列双交叉生物等效性试验预试验

[Translation] A pilot study on the randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover bioequivalence study of insulin aspart injection in Chinese healthy subjects

主要目的：采用正葡萄糖钳夹技术，在健康成年受试者中比较北京双鹭药业股份有限公司研制的门冬胰岛素注射液与诺和诺德公司研制生产的门冬胰岛素注射液单剂量皮下注射药代动力学的生物等效性试验预试验，为正式试验采血设计、钳夹试验设计提供依据。次要目的：评价门冬胰岛素注射液在健康成年受试者中的安全性。

[Translation]

Primary objective: To compare the pharmacokinetics of single-dose subcutaneous injection of insulin aspart injection developed by Beijing Shuanglu Pharmaceutical Co., Ltd. and insulin aspart injection developed and produced by Novo Nordisk in healthy adult subjects using the euglycemic clamp technique in a preliminary bioequivalence study, in order to provide a basis for the design of blood sampling and clamp experiments in the formal experiment. Secondary objective: To evaluate the safety of insulin aspart injection in healthy adult subjects.

Start Date28 Oct 2019

Sponsor / Collaborator

Beijing SL Pharmaceutical Co., Ltd.

100 Clinical Results associated with Insulin Aspart(Beijing SL Pharmaceutical Co., Ltd.)

100 Translational Medicine associated with Insulin Aspart(Beijing SL Pharmaceutical Co., Ltd.)

100 Patents (Medical) associated with Insulin Aspart(Beijing SL Pharmaceutical Co., Ltd.)

100 Deals associated with Insulin Aspart(Beijing SL Pharmaceutical Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
D04475	-	A10AD05 A10AB05	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	China	Beijing SL Pharmaceutical Co., Ltd.	18 Dec 2019

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