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非在研适应症- |
最高研发阶段批准上市 |
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首次获批日期2018-10-01 |
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非在研适应症- |
最高研发阶段批准上市 |
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首次获批日期2014-11-19 |
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最高研发阶段批准上市 |
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首次获批日期2012-08-30 |
评估阿地溴铵 400 μg 吸入给药在健康中国参与者中的药代动力学特性、安全性和耐受
性的一项 I 期、开放性标签、单剂和多剂(每日两次)临床试验
主要目的是评估阿地溴铵 400 μg 制剂在中国健康志愿者中单剂给药和多剂(每日二次)给药后,阿地溴铵及其代谢物的药代动力学(PK)特性。
次要目的是评估阿地溴铵 400 μg 制剂单剂给药和多剂(每日二次)给药在健康中国参与者中的安全性和耐受性。
在中重度慢性阻塞性肺疾病中国患者中评估阿地溴铵/富马酸福莫特罗的药代动力学、安全性和耐受性的临床试验
对处于稳定期的中重度 COPD 中国患者进行为期 5 天的阿地溴铵/福莫特罗 400μg/12μg 每日二次给药,评估阿地溴铵、其代谢物 LAS34850 和 LAS34823 以及福莫特罗的药代动力学特性,同时评估安全性和耐受性。
A Phase I, Single Centre, Randomised, Single Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Inhaled AZD8871 in Healthy Male Japanese Subjects.
AZD8871 is a new chemical entity possessing long-acting dual-pharmacology (muscarinic receptor antagonist and β2 adrenoceptor agonist [MABA]) in a single molecule. This type of agent presents a novel approach to the treatment of chronic obstructive pulmonary disease (COPD) and potentially asthma (in combination with an inhaled corticosteroid). AZD8871 is being developed for inhalation, formulated with alpha lactose monohydrate and delivered by dry powder inhaler (DPI) that allows delivery of a single dose of the study drug.
The primary objective is to investigate the safety and tolerability of AZD8871 at steady state in healthy male Japanese subjects.
100 项与 Industrias Farmacéuticas Almirall SA 相关的临床结果
0 项与 Industrias Farmacéuticas Almirall SA 相关的专利(医药)
100 项与 Industrias Farmacéuticas Almirall SA 相关的药物交易
100 项与 Industrias Farmacéuticas Almirall SA 相关的转化医学