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MechanismGABAA receptor agonists |
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乌帕替尼缓释片在空腹及餐后条件下的人体生物等效性研究
[Translation] Study on the human bioequivalence of upadatinib sustained-release tablets under fasting and postprandial conditions
主要目的:研究健康受试者在空腹及餐后状态下,单次口服由天地恒一制药股份有限公司生产的乌帕替尼缓释片【受试制剂T,规格:15mg(以乌帕替尼计)】与单次口服AbbVie Ireland NL B.V生产的乌帕替尼缓释片【参比制剂R,规格:15 mg(以乌帕替尼计),商品名:瑞福®】的药动学特征,评价两制剂间的生物等效性。
次要目的:评价中国健康成年受试者空腹和餐后状态下单次口服受试制剂乌帕替尼缓释片【15mg(以乌帕替尼计)】和参比试剂乌帕替尼缓释片【瑞福®,15mg(以乌帕替尼计)】的安全性。
[Translation] Main purpose: To study the efficacy of upadatinib sustained-release tablets produced by Tiandi Hengyi Pharmaceutical Co., Ltd. [test preparation T, specification: 15 mg (based on upadatinib) after a single oral administration in healthy subjects under fasting and postprandial conditions. Pharmacokinetics with single oral administration of upadatinib extended-release tablets produced by AbbVie Ireland NL B.V [Reference preparation R, specification: 15 mg (based on upadatinib), trade name: Ruifu®] chemical characteristics and evaluate the bioequivalence between the two preparations.
Secondary purpose: To evaluate the efficacy of single oral administration of the test preparation uppatinib extended-release tablets [15 mg (calculated as upatinib)] and the reference agent uppatinib extended-release tablets in Chinese healthy adult subjects in the fasting and postprandial states. Safety of release tablets [Refu®, 15mg (based on upadatinib)].
达比加群酯胶囊在空腹及餐后条件下的人体生物等效性研究
[Translation] Human bioequivalence study of dabigatran etexilate capsules under fasting and postprandial conditions
"主要目的:研究健康受试者在空腹及餐后状态下,单次口服由天地恒一制药股份有限公司生产的达比加群酯胶囊【受试制剂T,规格:110mg(以达比加群酯计)】与单次口服Boehringer Ingelheim Pharma GmbH & Co.KG生产的达比加群酯胶囊【参比制剂R,规格:110 mg,泰毕全®】的药动学特征,评价两制剂间的生物等效性。
次要目的:评价中国健康成年受试者空腹和餐后状态下单次口服受试制剂达比加群酯胶囊【110mg(以达比加群酯计)】和参比试剂达比加群酯胶囊【泰毕全®,110mg(以达比加群酯计)】的安全性。"
[Translation] "Main purpose: To study healthy subjects in the fasting and postprandial state, a single oral administration of dabigatran etexilate capsules produced by Tiandi Hengyi Pharmaceutical Co., Ltd. [Test preparation T, specification: 110mg (based on dabigatran Pharmacokinetic characteristics of dabigatran etexilate capsules produced by Boehringer Ingelheim Pharma GmbH & Co.KG [reference preparation R, strength: 110 mg, Pradaxa®]] and single oral administration of dabigatran etexilate capsules [reference preparation R, strength: 110 mg, Pradaxa®], and the evaluation of the two preparations bioequivalence between them.
Secondary purpose: To evaluate the test agent dabigatran etexilate capsule [110 mg (calculated as dabigatran etexilate)] and the reference agent dabigatran etexilate in the fasting and postprandial state of Chinese healthy adult subjects The safety of capsules [Phadaxa®, 110mg (calculated as dabigatran etexilate)]. "
[Translation] Human bioequivalence study of apixaban tablets under fasting and postprandial conditions
研究健康受试者在空腹及餐后状态下,单次口服由天地恒一制药股份有限公司生产的阿哌沙班片(受试制剂T,规格:2.5mg)与单次口服中国上市 ,生产厂家为Bristol-Myers Squibb Manufacturing Company的阿哌沙班片(参比制剂R,规格:2.5mg,商品名:Eliquis)的药动学特征,评价两制剂间的生物等效性。
[Translation] Study healthy subjects in fasting and after meal state, a single oral dose of apixaban tablets (test preparation T, specification: 2.5 mg) produced by Tiandi Hengyi Pharmaceutical Co., Ltd. and a single oral dose of apixaban tablets produced in China The manufacturer is Bristol-Myers Squibb Manufacturing Company's apixaban tablets (reference preparation R, strength: 2.5 mg, trade name: Eliquis), the pharmacokinetic characteristics, and the evaluation of the bioequivalence between the two preparations.
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