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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date10 Apr 2008 |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
瑞加诺生注射液用于负荷超声心动图试验诊断冠心病的多中心、随机、自身对照、阳性药对照的Ⅲ期临床研究
[Translation] Multicenter, randomized, self-controlled, positive drug-controlled phase III clinical study of Ruiganuosheng injection in the diagnosis of coronary heart disease by stress echocardiography
1、主要目的:以冠状动脉造影为金标准,评价与腺苷注射液相比,瑞加诺生注射液作为超声心动图负荷药物对于冠心病的诊断效能。
2、次要目的:评价与腺苷注射液相比,瑞加诺生注射液作为超声心动图负荷药物的安全性。
[Translation] 1. Main purpose: Taking coronary angiography as the gold standard, to evaluate the diagnostic efficacy of Reganoson Injection as an echocardiographic stress drug for coronary heart disease compared with adenosine injection.
2. Secondary purpose: To evaluate the safety of Reganoson Injection as an echocardiographic stress drug compared with Adenosine Injection.
度骨化醇注射液治疗慢性肾脏病血液透析合并继发性甲状旁腺功能亢进症患者的有效性和安全性的开放、单臂、多中心临床研究
[Translation] An open, single-arm, multi-center clinical study on the efficacy and safety of docalciferol injection in the treatment of chronic kidney disease patients with hemodialysis and secondary hyperparathyroidism
评价度骨化醇注射液治疗慢性肾脏病血液透析合并继发性甲状旁腺功能亢进症的患者的有效性和安全性。
[Translation] To evaluate the efficacy and safety of docalciferol injection in the treatment of chronic kidney disease hemodialysis patients with secondary hyperparathyroidism.
[14C]HR1405-01在中国成年男性健康受试者体内物质平衡研究
[Translation] [14C]HR1405-01 in vivo material balance study of Chinese adult male healthy subjects
主要研究目的:
1. 定量分析男性健康受试者静脉滴注[14C]HR1405-01注射液后排泄物中的总放射性,获得人体放射性排泄率数据和主要排泄途径;
2. 定量分析男性健康受试者静脉滴注[14C]HR1405-01注射液后全血与血浆总放射性、获得血浆中总放射性的药代动力学参数,并考察全血与血浆总放射性的分配情况;
3. 定量分析男性健康受试者静脉滴注[14C]HR1405-01注射液后人血浆、尿液和粪便中的放射性代谢物谱,鉴定主要代谢产物,确定主要生物转化途径和消除途径;
次要研究目的:
4. 定量分析血浆中HR1405-01及其代谢物(如适用)的浓度,获得药代动力学参数;
5. 观察男性健康受试者单剂量静脉滴注[14C]HR1405-01注射液后的安全性。
[Translation] Main research purposes:
1. Quantitatively analyze the total radioactivity in the excrement of male healthy subjects after intravenous infusion of [14C]HR1405-01 injection, and obtain the data of human radioactive excretion rate and main excretion route;
2. Quantitatively analyze the total radioactivity of whole blood and plasma after intravenous infusion of [14C]HR1405-01 injection in male healthy subjects, obtain the pharmacokinetic parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma Condition;
3. Quantitatively analyze the spectrum of radioactive metabolites in human plasma, urine and feces after intravenous infusion of [14C]HR1405-01 injection in male healthy subjects, identify the main metabolites, and determine the main biotransformation and elimination routes;
Secondary research purposes:
4. Quantitatively analyze the concentration of HR1405-01 and its metabolites (if applicable) in plasma to obtain pharmacokinetic parameters;
5. To observe the safety of male healthy subjects after single-dose intravenous infusion of [14C]HR1405-01 injection.
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