4
Clinical Trials associated with Esomeprazole Magnesium/Sodium Bicarbonate艾司奥美拉唑镁碳酸氢钠干混悬剂(I)在中国健康成人中单次和多次给药的药代动力学、药效动力学以及食物影响试验
[Translation] Pharmacokinetics, pharmacodynamics and food effect of single and multiple doses of esomeprazole magnesium sodium bicarbonate suspension (I) in healthy Chinese adults
以健康受试者为试验对象,艾司奥美拉唑镁碳酸氢钠干混悬剂(I)(规格为每袋含艾司奥美拉唑镁(按C17H19N3O3S计)20mg与碳酸氢钠1680mg)为受试制剂,艾司奥美拉唑碳酸氢钠胶囊(规格为每粒含艾司奥美拉唑镁(按C17H19N3O3S计)20mg与碳酸氢钠1100mg)为参比制剂,采用单次和多次给药试验设计,进行两制剂药代动力学、药效动力学比较试验以及食物对受试制剂PK参数影响试验:
1. 比较单次和多次给药后受试制剂和参比制剂药代动力学参数;
2. 比较单次和多次给药后受试制剂和参比制剂药效动力学参数;
3. 评价食物对受试制剂药代动力学参数的影响;
4. 观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Healthy subjects were used as test subjects, esomeprazole magnesium sodium bicarbonate dry suspension (I) (specification: each bag contains 20 mg of esomeprazole magnesium (calculated as C17H19N3O3S) and 1680 mg of sodium bicarbonate) as the test preparation, and esomeprazole sodium bicarbonate capsules (specification: each capsule contains 20 mg of esomeprazole magnesium (calculated as C17H19N3O3S) and 1100 mg of sodium bicarbonate) as the reference preparation. Single and multiple dosing test designs were used to conduct pharmacokinetic and pharmacodynamic comparison tests of the two preparations and the effect of food on the PK parameters of the test preparation:
1. Compare the pharmacokinetic parameters of the test preparation and the reference preparation after single and multiple dosing;
2. Compare the pharmacodynamic parameters of the test preparation and the reference preparation after single and multiple dosing;
3. Evaluate the effect of food on the pharmacokinetic parameters of the test preparation;
4. Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
XY066在中国健康成人中的药代动力学、药效动力学及安全性研究
[Translation] Study on the pharmacokinetics, pharmacodynamics and safety of XY066 in healthy Chinese adults
在中国健康成年受试者中,评价长春海悦药业股份有限公司生产的受试制剂XY066和原研参比制剂的药代动力学及药效动力学的生物等效性,以及安全性和耐受性。
[Translation] To evaluate the pharmacokinetics and pharmacodynamics bioequivalence, as well as the safety and tolerability of the test formulation XY066 produced by Changchun Haiyue Pharmaceutical Co., Ltd. and the original reference formulation in healthy adult subjects in China.
艾司奥美拉唑镁碳酸氢钠干混悬剂(II)在中国健康成人中单次和多次给药的药代动力学、药效动力学以及食物影响试验
[Translation] Pharmacokinetics, pharmacodynamics and food effect of single and multiple doses of esomeprazole magnesium sodium bicarbonate suspension (II) in healthy Chinese adults
以健康受试者为试验对象,艾司奥美拉唑镁碳酸氢钠干混悬剂(II)为受试制剂,艾司奥美拉唑镁肠溶片(耐信®,按C17H19N3O3S计40mg)为参比制剂,采用单次和多次给药试验设计,进行两制剂药代动力学、药效动力学比较试验以及食物对受试制剂PK参数影响试验:
1. 比较单次和多次给药后受试制剂和参比制剂药代动力学参数;
2. 比较单次和多次给药后受试制剂和参比制剂药效动力学参数;
3. 评价食物对受试制剂药代动力学参数的影响;
4. 观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Healthy subjects were used as test subjects, esomeprazole magnesium sodium bicarbonate dry suspension (II) was the test preparation, and esomeprazole magnesium enteric-coated tablets (Nexium®, 40 mg based on C17H19N3O3S) was the reference preparation. Single and multiple dosing test designs were used to conduct pharmacokinetic and pharmacodynamic comparison tests of the two preparations and the effect of food on the PK parameters of the test preparation:
1. Compare the pharmacokinetic parameters of the test preparation and the reference preparation after single and multiple dosing;
2. Compare the pharmacodynamic parameters of the test preparation and the reference preparation after single and multiple dosing;
3. Evaluate the effect of food on the pharmacokinetic parameters of the test preparation;
4. Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Esomeprazole Magnesium/Sodium Bicarbonate
100 Translational Medicine associated with Esomeprazole Magnesium/Sodium Bicarbonate
100 Patents (Medical) associated with Esomeprazole Magnesium/Sodium Bicarbonate
100 Deals associated with Esomeprazole Magnesium/Sodium Bicarbonate