A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Dabigatran Etexilate Capsules 150 mg and Reference Product (Pradaxa®) in Healthy Thai Volunteers Under Fasting Conditions and Under Pre-treatment With a Proton Pump Inhibitor
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran.
Open-label, Single-center Study in Healthy Subjects to Investigate the Effect of Oral Givinostat on Pharmacokinetics (PK) of Intravenous and Oral Midazolam and Oral Dabigatran Etexilate (PART 1)
Primary objective:
1. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose pharmacokinetics (PK) of intravenous or oral midazolam.
2. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose PK of oral dabigatran etexilate.
Secondary objective:
To assess the safety and tolerability of concomitant administration of givinostat plus midazolam and dabigatran etexilate.
A randomized controlled study for the effect of Rivaroxaban ,Warfarin,Dabigatran etexilate on the recurrence of non-valvularatrial fibrillation after catheterradio frequency ablation and mechanism exploration
100 项与 达比加群酯甲苯磺酸盐 相关的临床结果
100 项与 达比加群酯甲苯磺酸盐 相关的转化医学
100 项与 达比加群酯甲苯磺酸盐 相关的专利(医药)
1
项与 达比加群酯甲苯磺酸盐 相关的新闻(医药)4月25日,恒瑞公告表示,其子公司北京盛迪医药的1类新药SHR-2004注射液获批临床,拟用于预防或治疗动静脉血栓。数据显示,2020年中国公立医疗机构终端抗血栓形成药销售额超过300亿元,目前恒瑞已有3款抗血栓形成药获批上市,其中磺达肝癸钠注射液已拿下第七批集采入场券。
据公告显示,SHR-2004注射液为大分子生物制剂,拟用于预防或治疗动静脉血栓,目前国内外尚无同类品种上市。截至目前,SHR-2004注射液相关项目累计已投入研发费用约2127万元。
数据显示,除了SHR-2004注射液,恒瑞另一款1类抗血栓形成药SHR2285片已步入临床Ⅰ期阶段。目前恒瑞已上市的抗血栓形成药包括盐酸噻氯匹定片、磺达肝癸钠注射液以及阿司匹林双嘧达莫缓释胶囊3款。
近年来,在支架国采的推动下,抗血栓形成药市场迎来增长新机。数据显示,2020年中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院(简称中国公立医疗机构)终端抗血栓形成药销售额超过300亿元,受到疫情影响与往年相比稍稍下降,2021年上半年超过170亿元,同比增长13.89%。但头部市场主要由拜耳、赛诺菲以及勃林格殷格翰等海外企业所占据。
目前利伐沙班片、阿哌沙班片、达比加群酯胶囊、硫酸氢氯吡格雷片、替格瑞洛片、注射用比伐芦定6款抗血栓形成药已被纳入集采,其中硫酸氢氯吡格雷片为首个被纳入国采的抗血栓形成药,赛诺菲、乐普、石药以及信立泰等企业中选。在即将开展的第七批集采中,磺达肝癸钠注射剂、替罗非班注射剂以及依替巴肽注射剂3款抗血栓形成药已被纳入集采范围,恒瑞的磺达肝癸钠注射剂已拿下入场券。
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100 项与 达比加群酯甲苯磺酸盐 相关的药物交易