[Translation] Single-center, open, randomized, single-dose, double-period, double-crossover bioequivalence study of isosorbide mononitrate extended-release tablets (60mg) 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] Pre-test
The main purpose: to verify the analytical method of this test under the conditions of fasting and postprandial administration, and at the same time evaluate the Isosorbide Mononitrate Sustained-release Tablets (specification: 60mg) provided by Tibet Nuodikang Technology Development Co., Ltd. and AstraZeneca Pharmaceuticals Co., Ltd.'s Isosorbide Mononitrate Sustained-release Tablets (trade name: Yimuduo, specification: 60mg) in the difference in absorption degree and speed in healthy adults, conduct a comparative pharmacokinetic study of the two, and at the same time verify the analysis method, Rationality of the test procedure, blood collection points and test design.
Secondary purpose: To evaluate the safety of Isosorbide Mononitrate Sustained-release Tablets (Specification: 60mg) provided by Tibet Nuodikang Technology Development Co., Ltd. in healthy subjects under fasting and postprandial administration conditions.
formal test
Main purpose: To compare the Isosorbide Mononitrate Sustained-release Tablets (Specification: 60mg) provided by Tibet Nuodikang Technology Development Co., Ltd. and the Isosorbide Mononitrate of AstraZeneca Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions The differences in the degree and speed of absorption of sustained-release tablets (trade name: Imdo®, specification: 60mg) in healthy adults were evaluated for their bioequivalence.
Secondary purpose: To evaluate the safety of Isosorbide Mononitrate Sustained-release Tablets (Specification: 60mg) provided by Tibet Nuodikang Technology Development Co., Ltd. in healthy subjects under fasting and postprandial administration conditions.