[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of isosorbide mononitrate extended-release tablets (30 mg) in Chinese healthy subjects under fasting and fed conditions.

主要目的：在空腹及餐后给药条件下，比较西藏诺迪康科技发展有限公司提供的单硝酸异山梨酯缓释片（规格：30mg）与阿斯利康制药有限公司的单硝酸异山梨酯缓释片（商品名：依姆多，规格：30mg）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹及餐后给药条件下，西藏诺迪康科技发展有限公司提供的单硝酸异山梨酯缓释片（规格：30mg）在健康受试者中的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and speed between the isosorbide mononitrate sustained-release tablets (specification: 30 mg) provided by Tibet Nordicon Technology Development Co., Ltd. and the isosorbide mononitrate sustained-release tablets (trade name: Imodo, specification: 30 mg) provided by AstraZeneca Pharmaceuticals Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of the isosorbide mononitrate sustained-release tablets (specification: 30 mg) provided by Tibet Nordicon Technology Development Co., Ltd. in healthy subjects under fasting and postprandial administration conditions.

Start Date03 Apr 2023

Sponsor / Collaborator

Tibet Nuodikang Technology Development Co., Ltd.

CTR20223396 / CompletedNot Applicable

单硝酸异山梨酣缓释片 (60mg) 在中国健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹及餐后状态下的生物等效性试验。

[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of isosorbide mononitrate extended-release tablets (60 mg) in Chinese healthy subjects under fasting and fed conditions.

预试验主要目的：在空腹及餐后给药条件下，验证本试验的分析方法，同时评估西藏诺迪康科技发展有限公司提供的单硝酸异山梨酯缓释片（规格：60mg）与阿斯利康制药有限公司的单硝酸异山梨酯缓释片（商品名：依姆多，规格：60mg）在健康成年人群中吸收程度和速度的差异，进行两者药代动力学比较研究，同时验证分析方法、试验流程、采血点和试验设计的合理性。次要目的：评价空腹及餐后给药条件下，西藏诺迪康科技发展有限公司提供的单硝酸异山梨酯缓释片（规格：60mg）在健康受试者中的安全性。正式试验主要目的：在空腹及餐后给药条件下，比较西藏诺迪康科技发展有限公司提供的单硝酸异山梨酯缓释片（规格：60mg）与阿斯利康制药有限公司的单硝酸异山梨酯缓释片（商品名：依姆多®，规格：60mg）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹及餐后给药条件下，西藏诺迪康科技发展有限公司提供的单硝酸异山梨酯缓释片（规格：60mg）在健康受试者中的安全性。

[Translation]

Preliminary study Main purpose: To verify the analytical method of this study under fasting and postprandial administration conditions, and to evaluate the difference in absorption degree and speed between the isosorbide mononitrate sustained-release tablets (specification: 60 mg) provided by Tibet Nordicon Technology Development Co., Ltd. and the isosorbide mononitrate sustained-release tablets (trade name: Imodo, specification: 60 mg) of AstraZeneca Pharmaceuticals Co., Ltd. in healthy adults, to conduct a pharmacokinetic comparison between the two, and to verify the rationality of the analytical method, experimental process, blood collection points and experimental design. Secondary purpose: To evaluate the safety of the isosorbide mononitrate sustained-release tablets (specification: 60 mg) provided by Tibet Nordicon Technology Development Co., Ltd. in healthy subjects under fasting and postprandial administration conditions. Formal trial Main purpose: To compare the differences in absorption degree and speed between the isosorbide mononitrate sustained-release tablets (specification: 60 mg) provided by Tibet Nordicon Technology Development Co., Ltd. and the isosorbide mononitrate sustained-release tablets (trade name: Imodo®, specification: 60 mg) of AstraZeneca Pharmaceuticals Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary purpose: To evaluate the safety of the isosorbide mononitrate sustained-release tablets (specification: 60 mg) provided by Tibet Nordicon Technology Development Co., Ltd. in healthy subjects under fasting and postprandial administration conditions.

Start Date03 Jan 2023

Sponsor / Collaborator

Tibet Nuodikang Technology Development Co., Ltd.

100 Clinical Results associated with Tibet Nuodikang Technology Development Co., Ltd.

0 Patents (Medical) associated with Tibet Nuodikang Technology Development Co., Ltd.

100 Deals associated with Tibet Nuodikang Technology Development Co., Ltd.

100 Translational Medicine associated with Tibet Nuodikang Technology Development Co., Ltd.

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