盐酸达泊西汀片（60mg）在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两制剂、自身交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, self-crossover bioequivalence study of dapoxetine hydrochloride tablets (60 mg) in healthy Chinese subjects under fasting and fed conditions
主要目的：按有关生物等效性试验的规定，选择Berlin-Chemie AG为持证商的盐酸达泊西汀片（商品名：Priligy®，规格：60mg）为参比制剂，对云南龙津康佑生物医药有限公司持证的受试制剂盐酸达泊西汀片（规格：60mg）进行空腹及餐后给药条件下的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹及餐后给药条件下的生物等效性。
次要目的：观察健康受试者口服受试制剂盐酸达泊西汀片（规格：60mg）和参比制剂盐酸达泊西汀片（商品名：Priligy®，规格：60mg）的安全性。
[Translation] Main purpose: According to the relevant provisions of bioequivalence test, dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 60 mg) with Berlin-Chemie AG as the licensee were selected as the reference preparation, and the human bioequivalence test of the test preparation dapoxetine hydrochloride tablets (specification: 60 mg) with Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd. was conducted under fasting and postprandial administration conditions to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary purpose: To observe the safety of oral administration of the test preparation dapoxetine hydrochloride tablets (specification: 60 mg) and the reference preparation dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 60 mg) to healthy subjects.
依折麦布片在健康成年受试者中随机、开放、两制剂、四周期、交叉设计生物等效性研究
[Translation] A randomized, open-label, two-dose, four-period, crossover bioequivalence study of ezetimibe tablets in healthy adult subjects
本试验旨在研究单次空腹和餐后口服由云南龙津康佑生物医药有限公司提供、昆明龙津药业股份有限公司生产的依折麦布片（10 mg）的药代动力学特征；以MSD International GmbH（Singapore Branch）生产的依折麦布片（益适纯®，10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察两制剂在健康受试者中的安全性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of single fasting and postprandial oral administration of ezetimibe tablets (10 mg) provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd. and produced by Kunming Longjin Pharmaceutical Co., Ltd.; using ezetimibe tablets (Esperidone®, 10 mg) produced by MSD International GmbH (Singapore Branch) as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, to evaluate the human bioequivalence of the two preparations, and to observe the safety of the two preparations in healthy subjects.
枸橼酸西地那非口崩片在健康成年男性受试者中随机、开放、两制剂、两周期、双交叉空腹状态下生物等效性研究
[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of sildenafil citrate orodisintegrating tablets in healthy adult male subjects under fasting conditions
主要研究目的
研究空腹状态下单次口服受试制剂枸橼酸西地那非口崩片（规格：50 mg，由昆明龙津药业股份有限公司生产，云南龙津康佑生物医药有限公司提供）与枸橼酸西地那非口崩片（万艾可®，规格：50 mg；由Pfizer Limited持证，云南龙津康佑生物医药有限公司提供）在健康成年男性受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。
次要研究目的
研究受试制剂枸橼酸西地那非口崩片和参比制剂枸橼酸西地那非口崩片（万艾可®）在健康成年男性受试者中的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation sildenafil citrate orodisintegrating tablets (specification: 50 mg, produced by Kunming Longjin Pharmaceutical Co., Ltd., provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd.) and sildenafil citrate orodisintegrating tablets (Viagra®, specification: 50 mg; licensed by Pfizer Limited, provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd.) in healthy adult male subjects in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state.
Secondary study objectives
To study the safety of the test preparation sildenafil citrate orodisintegrating tablets and the reference preparation sildenafil citrate orodisintegrating tablets (Viagra®) in healthy adult male subjects.
100 Clinical Results associated with Yunnan Longjin Kangyou Biomedical Co., Ltd.
0 Patents (Medical) associated with Yunnan Longjin Kangyou Biomedical Co., Ltd.
100 Deals associated with Yunnan Longjin Kangyou Biomedical Co., Ltd.
100 Translational Medicine associated with Yunnan Longjin Kangyou Biomedical Co., Ltd.
