[Translation] Human bioequivalence clinical trial of ezetimibe and atorvastatin calcium tablets in Chinese healthy people after single administration in fasting and postprandial states
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:每片含依折表布10mg与阿托伐他汀钙20mg(以C33H35FN2O5计))为参比制剂,以湖北民康药业集团有限公司研发的依折麦布阿托伐他汀钙片(每片含依折表布10mg与阿托伐他汀钙20mg(以C33H35FN2O5计))为受试制剂,通过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] Main purpose: The licensee is Organon Healthcare GmbH’s ezetimibe and atorvastatin calcium tablets (trade name: Atozet®, specifications: each tablet contains ezetimibe 10 mg and atorvastatin calcium 20 mg (calculated as C33H35FN2O5 )) is the reference preparation, using ezetimibe and atorvastatin calcium tablets developed by Hubei Minkang Pharmaceutical Group Co., Ltd. (each tablet contains ezetimibe 10 mg and atorvastatin calcium 20 mg (calculated as C33H35FN2O5)) For the test preparations, clinical trials were conducted to evaluate the bioequivalence of the two preparations in Chinese healthy subjects under fasting and postprandial conditions.
Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.