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MechanismHIF-PHs inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date29 Jun 2020 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date13 Jan 2016 |
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Mechanism5-HT1A receptor agonists [+2] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date10 Jul 2015 |
比较达普司他片和人促红素注射液治疗非透析慢性肾脏病患者肾性贫血的有效性和安全性的Ⅲ期临床研究
[Translation] A Phase III clinical trial comparing the efficacy and safety of dapoxetine tablets and human erythropoietin injection in the treatment of renal anemia in non-dialysis chronic kidney disease patients.
主要目的: 以人促红素注射液为对照,评估达普司他治疗非透析慢性肾脏病(CKD)参与者肾性贫血的有效性。
次要目的: 以人促红素注射液为对照,评估达普司他治疗非透析CKD参与者肾性贫血的安全性。
[Translation] Primary objective: To evaluate the efficacy of daprestat in treating renal anemia in non-dialysis chronic kidney disease (CKD) participants, using human erythropoietin injection as a control.
Secondary objective: To evaluate the safety of daprestat in treating renal anemia in non-dialysis CKD participants, using human erythropoietin injection as a control.
比较达普司他片和达依泊汀α注射液治疗维持性血液透析慢性肾脏病患者肾性贫血的有效性和安全性的Ⅲ期临床研究
[Translation] A Phase III clinical trial comparing the efficacy and safety of dapoxetine tablets and dapoxetine alpha injection in the treatment of renal anemia in patients with chronic kidney disease undergoing maintenance hemodialysis.
主要目的:以达依泊汀α注射液为对照,评估达普司他片治疗维持性血液透析慢性肾脏病(CKD)参与者肾性贫血的有效性。 次要目的:以达依泊汀α注射液为对照,评估达普司他片治疗维持性血液透析CKD参与者肾性贫血的安全性
[Translation] Primary objective: To evaluate the efficacy of daprestat tablets in treating renal anemia in maintenance hemodialysis participants with chronic kidney disease (CKD), using daprestat alpha injection as a control. Secondary objective: To evaluate the safety of daprestat tablets in treating renal anemia in maintenance hemodialysis participants with CKD, using daprestat alpha injection as a control.
BCM476胶囊与盐酸奈必洛尔片及苯磺酸氨氯地平片的药代动力学比较研究
[Translation] Comparative pharmacokinetic study of BCM476 capsules with nebivolol hydrochloride tablets and amlodipine besylate tablets
主要目的
观察BCM476胶囊在中国健康受试者中单次口服给药后体内动力学过程,估算相应的药代动力学参数,并以盐酸奈必洛尔片(NEBILETTM)和苯磺酸氨氯地平片(络活喜®),进行药代动力学比较研究,以确定本品中的活性成份不存在药代动力学相互作用。 次要研究目的
观察BCM476胶囊受试制剂(T)和对照制剂(R1)盐酸奈必洛尔片以及对照制剂(R2)苯磺酸氨氯地平片在中国健康人体中的安全性。
[Translation] Primary Objective: To observe the pharmacokinetic process of BCM476 capsules in healthy Chinese subjects after a single oral administration, estimate the corresponding pharmacokinetic parameters, and conduct a pharmacokinetic comparison study with nebivolol hydrochloride tablets (NEBILET™) and amlodipine besylate tablets (Norvasc®) to determine that there are no pharmacokinetic interactions between the active ingredients in this product. Secondary Objective: To observe the safety of the test formulation (T) and control formulations (R1) nebivolol hydrochloride tablets and (R2) amlodipine besylate tablets in healthy Chinese subjects.
100 Clinical Results associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.
100 Deals associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.