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Clinical Trials associated with Lansoprazole/Sodium Bicarbonate兰索拉唑碳酸氢钠干混悬剂(30mg/1680mg)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 studies of single and multiple doses of lansoprazole sodium bicarbonate suspension (30 mg/1680 mg) in healthy Chinese adults
以健康受试者为试验对象,兰索拉唑碳酸氢钠干混悬剂(30mg/1680mg)为受试制剂,兰索拉唑碳酸氢钠胶囊(30mg/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, lansoprazole sodium bicarbonate dry suspension (30mg/1680mg) was used as the test preparation, and lansoprazole sodium bicarbonate capsule (30mg/1100mg) was used 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.
兰索拉唑碳酸氢钠干混悬剂(15mg/1680mg)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 studies of single and multiple doses of lansoprazole sodium bicarbonate suspension (15 mg/1680 mg) in healthy Chinese adults
以健康受试者为试验对象,以兰索拉唑碳酸氢钠干混悬剂(15mg/1680mg)为受试制剂,以兰索拉唑肠溶胶囊(Takepron®,15mg)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, lansoprazole sodium bicarbonate dry suspension (15mg/1680mg) was used as the test preparation, and lansoprazole enteric-coated capsules (Takepron®, 15mg) was used 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.
A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Compare and Evaluate the Safety, PK and PD Characteristics After Oral Administration of IY-NS250 and IY-NT-SR in Healthy Adult Volunteers
This study comparative evaluation of safety and pharmacokinetic and pharmacodynamic properties in oral repeat administration of IY-NS250 and IY-NT-SR in healthy adult
100 Clinical Results associated with Lansoprazole/Sodium Bicarbonate
100 Translational Medicine associated with Lansoprazole/Sodium Bicarbonate
100 Patents (Medical) associated with Lansoprazole/Sodium Bicarbonate
100 Deals associated with Lansoprazole/Sodium Bicarbonate