Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
|
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项在健康受试者中评估HRN01片安全性、耐受性的随机、双盲、安慰剂对照的I期临床研究
[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety and tolerability of HRN01 tablets in healthy subjects
主要目的:
1.评价在健康受试者中单次、多次口服HRN01片后的安全性、耐受性;
2.评价食物(高脂高热量餐)对HRN01片药代动力学的影响。
次要目的:
1.评价在健康受试者中单次、多次口服HRN01片后的药代动力学特征;
2.评价HRN01片在健康受试者中的代谢与排泄特征;
3.评价HRN01片单次给药后对健康受试者QTc间期的影响;
4.评价健康受试者在餐后状态下(高脂高热量餐)口服HRN01片的安全性和耐受性。
探索性目的:
探索在健康受试者中多次口服HRN01片后的药效学指标。
[Translation] Main objectives:
1. To evaluate the safety and tolerability of HRN01 tablets after single and multiple oral administration in healthy subjects;
2. To evaluate the effect of food (high-fat and high-calorie meal) on the pharmacokinetics of HRN01 tablets.
Secondary objectives:
1. To evaluate the pharmacokinetic characteristics of HRN01 tablets after single and multiple oral administration in healthy subjects;
2. To evaluate the metabolism and excretion characteristics of HRN01 tablets in healthy subjects;
3. To evaluate the effect of single administration of HRN01 tablets on the QTc interval of healthy subjects;
4. To evaluate the safety and tolerability of oral administration of HRN01 tablets in healthy subjects in the postprandial state (high-fat and high-calorie meal).
Exploratory objectives:
To explore the pharmacodynamic indicators of HRN01 tablets after multiple oral administration in healthy subjects.
注射用右旋雷贝拉唑钠治疗急性非静脉曲张性上消化道出血的随机、单盲、阳性药平行对照、多中心临床试验
[Translation] A randomized, single-blind, positive-drug parallel-controlled, multicenter clinical trial of dextrabeprazole sodium for injection in the treatment of acute non-varicose upper gastrointestinal bleeding
评价注射用右旋雷贝拉唑钠治疗急性非静脉曲张性上消化道出血的有效性和安全性
[Translation] To evaluate the efficacy and safety of dextrabeprazole sodium for injection in the treatment of acute non-variceal upper gastrointestinal bleeding
评价不同剂量注射用右旋雷贝拉唑钠对健康志愿者胃内pH值影响的随 机、开放、阳性药平行对照的PK/PD研究
[Translation] A randomized, open-label, positive-drug parallel-controlled PK/PD study to evaluate the effects of different doses of dextrabeprazole sodium for injection on gastric pH in healthy volunteers
评价不同剂量注射用右旋雷贝拉唑钠药物代谢动力学特征,以及对健康志愿者胃内pH值的影响,同时评价安全性。 分析注射用右旋雷贝拉唑钠药物代谢动力学和药物效应动力学参数之间的量效相关性,以及与注射用雷贝拉唑钠药物代谢动力学暴露的比较,探索注射用右旋雷贝拉唑钠合适剂量范围,为后期临床试验提供理论依据。
[Translation] To evaluate the pharmacokinetic characteristics of different doses of dexrabeprazole sodium for injection, as well as the effects on gastric pH of healthy volunteers, and to evaluate safety. To analyze the dose-effect correlation between the pharmacokinetic and pharmacodynamic parameters of dexrabeprazole sodium for injection, and to compare the pharmacokinetic exposure of dexrabeprazole sodium for injection, to explore the appropriate dose range of dexrabeprazole sodium for injection, and to provide a theoretical basis for later clinical trials.
100 Clinical Results associated with Beijing Huarui Dingxin Technology Co., Ltd
0 Patents (Medical) associated with Beijing Huarui Dingxin Technology Co., Ltd
100 Deals associated with Beijing Huarui Dingxin Technology Co., Ltd
100 Translational Medicine associated with Beijing Huarui Dingxin Technology Co., Ltd