美阿沙坦钾片在健康受试者中餐后状态下的开放、随机、交叉生物等效性试验
[Translation] An open, randomized, crossover bioequivalence study of Asartan Potassium Tablets in healthy volunteers in the fed state
主要试验目的
研究餐后状态下单次口服受试制剂美阿沙坦钾片（规格：80mg，浙江华润三九众益制药有限公司生产）与参比制剂美阿沙坦钾片（商品名：易达比®；规格：80mg；Takeda Ireland Ltd.生产）在健康受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。
次要试验目的
评估受试制剂美阿沙坦钾片（规格：80mg）与参比制剂易达比®（规格：80mg）在健康受试者中的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg, produced by Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (trade name: Edabi®; Specification: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state.
Secondary study objectives
To evaluate the safety of the test preparation, Asartan Potassium Tablets (Specification: 80 mg) and the reference preparation, Edabi® (Specification: 80 mg) in healthy subjects.
罗沙司他胶囊在健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of roxadustat capsules in healthy subjects under fasting and fed conditions
主要研究目的：以珐博进（中国）医药技术开发有限公司持证的罗沙司他胶囊（商品名：爱瑞卓）为参比制剂，以浙江高跖医药科技股份有限公司持有的罗沙司他胶囊为受试制剂，通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂的人体生物等效性。
次要研究目的：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] The main purpose of the study is to use Rosuvastatin Capsules (trade name: Aeridro) licensed by FibroGen (China) Pharmaceutical Technology Development Co., Ltd. as the reference preparation and Rosuvastatin Capsules owned by Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in humans through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
氟伐他汀钠缓释片在健康受试者中餐后状态下的单剂量、随机、开放、四周期、两序列、重复交叉设计的生物等效性试验
[Translation] A single-dose, randomized, open-label, four-period, two-sequence, repeated crossover bioequivalence study of fluvastatin sodium extended-release tablets in healthy volunteers in the fed state
主要研究目的：研究餐后状态下单次口服受试制剂氟伐他汀钠缓释片（规格：80mg/片，浙江高跖医药科技股份有限公司）与参比制剂氟伐他汀钠缓释片（商品名：来适可®，规格：80mg/片，北京诺华制药有限公司）在健康成年受试者体内的药代动力学，评价两制剂的生物等效性。
次要研究目的：评价健康受试者餐后单次口服受试制剂（T）氟伐他汀钠缓释片和参比制剂（R）氟伐他汀钠缓释片（来适可®）后的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation fluvastatin sodium sustained-release tablets (specification: 80 mg/tablet, Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd.) and the reference preparation fluvastatin sodium sustained-release tablets (trade name: Lescol®, specification: 80 mg/tablet, Beijing Novartis Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations.
Secondary purpose of the study: to evaluate the safety of the test preparation (T) fluvastatin sodium sustained-release tablets and the reference preparation (R) fluvastatin sodium sustained-release tablets (Lescol®) after a single oral administration in healthy subjects.
100 Clinical Results associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
0 Patents (Medical) associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
100 Deals associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
