盐酸非索非那定口服混悬液在中国健康人群中单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of fexofenadine hydrochloride oral suspension in healthy Chinese people after a single dose
主要目的:以持证商为Chattem, Inc., d/b/a Sanofi Consumer Healthcare的盐酸非索非那定口服混悬液(商品名:Children’s Allegra Allergy,规格:30mg/5ml)为参比制剂,以河南上恒医药科技有限公司研发的盐酸非索非那定口服混悬液(规格:120ml:720mg)为受试制剂,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of fexofenadine hydrochloride oral suspension (trade name: Children’s Allegra Allergy, specification: 30mg/5ml) from Chattem, Inc., d/b/a Sanofi Consumer Healthcare as the reference preparation and fexofenadine hydrochloride oral suspension (specification: 120ml: 720mg) developed by Henan Shangheng Pharmaceutical Technology Co., Ltd. as the test preparation in Chinese healthy subjects in fasting and fed state.
Secondary objective: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
依折麦布阿托伐他汀钙片在中国健康人群中单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of single-dose ezetimibe and atorvastatin calcium tablets in healthy Chinese subjects
主要目的:以持证商为 Organon Healthcare GmbH 的依折麦布阿托伐他汀钙片(商品名:Atozet®,规格:每片含10mg依折麦布和20mg阿托伐他汀)为参比制剂,以河南上恒医药科技有限公司的依折麦布阿托伐他汀钙片(每片含10mg依折麦布和20mg 阿托伐他汀)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、三序列、三周期、部分重复交叉设计的临床试验来评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。 次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in the fasting and fed state in healthy Chinese subjects through a single-center, randomized, open, single-dose, two-preparation, three-sequence, three-period, partially repeated crossover clinical trial, using the reference preparation of Ezetimibe Atorvastatin Calcium Tablets (trade name: Atozet®, specification: each tablet contains 10 mg ezetimibe and 20 mg atorvastatin) produced by the licensee Organon Healthcare GmbH as the reference preparation and the test preparation of Ezetimibe Atorvastatin Calcium Tablets (each tablet contains 10 mg ezetimibe and 20 mg atorvastatin) produced by Henan Shangheng Pharmaceutical Technology Co., Ltd. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Henan Shangheng Pharmaceutical Technology Co., Ltd.
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100 Translational Medicine associated with Henan Shangheng Pharmaceutical Technology Co., Ltd.