[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-drug, two-sequence, two-cycle crossover bioequivalence of metformin empagliflozin tablets (I) in Chinese adult healthy subjects Research
主要研究目的:考察单次单剂量口服(空腹/餐后)受试制剂二甲双胍恩格列净片(I)(规格:500mg/5mg,海南中旺医疗科技开发有限公司委托海南葫芦娃药业集团股份有限公司生产)与参比制剂二甲双胍恩格列净片(I)(SYNJARDY®,规格:500mg/5mg,Boehringer Ingelheim Pharmaceuticals Inc 持证),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性
[Translation] The main purpose of the study: To investigate the test preparation Metformin Empagliflozin Tablets (I) (Specification: 500mg/5mg), which was entrusted by Hainan Zhongwang Medical Technology Development Co., Ltd. to Hainan Huluwa Pharmaceutical Group Co., Ltd.) and the reference preparation Metformin Empagliflozin Tablets (I) (SYNJARDY®, specification: 500mg/5mg, licensed by Boehringer Ingelheim Pharmaceuticals Inc), the relative bioavailability of the two preparations in Chinese healthy subjects was analyzed The pharmacokinetic parameters of the two preparations were evaluated to provide a reference for the application and clinical application of the drug.
Secondary research purpose: To evaluate the safety of a single oral administration of the test preparation and the reference preparation on an empty stomach and after a meal in Chinese adult healthy subjects