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] Randomized, open-label, two-drug, four-period, crossover design 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] The purpose of this experiment is to study the pharmacokinetic characteristics of ezetimibe tablets (10 mg) provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd. Ezetimibe Tablets (Ezetimibe®, 10 mg) produced by MSD International GmbH (Singapore Branch) was used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations were compared, and the human body effects of the two preparations were evaluated. Bioequivalence, and 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] Randomized, open-label, two-drug, two-period, double-crossover bioequivalence study of orally disintegrating sildenafil citrate tablets in healthy adult male subjects
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 research purpose
In the fasting state, the test preparation sildenafil citrate orally disintegrating tablets (specification: 50 mg, produced by Kunming Longjin Pharmaceutical Co., Ltd., provided by Yunnan Longjin Kangyou Biomedicine Co., Ltd.) and citron Pharmacokinetics of sildenafil acid orally disintegrating tablets (Viagra®, specification: 50 mg; licensed by Pfizer Limited, provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd.) in healthy adult male subjects, evaluating the fasting state Oral bioequivalence of the two formulations.
Secondary research purpose
To study the safety of the test preparation Sildenafil Citrate Orally Disintegrating Tablets and the reference preparation Sildenafil Citrate Orally Disintegrating Tablets (Viagra®) in healthy adult male subjects.
奥美沙坦酯氨氯地平片在空腹及餐后条件下的人体生物等效性试验
[Translation] Human bioequivalence test of olmesartan medoxomil and amlodipine tablets under fasting and postprandial conditions
本研究考察健康受试者在空腹及餐后条件下,单次口服由云南龙津康佑生物医药有限公司提供的
奥美沙坦酯氨氯地平片(受试制剂,规格:20 mg/5 mg)或由 Daiichi Sankyo Europe GmbH 持证及生
产的奥美沙坦酯氨氯地平片(参比制剂,商品名:Sevikar®,规格:20 mg/5 mg)的药动学特征,评价
两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] In this study, healthy subjects received a single oral dose of the drug provided by Yunnan Longjin Kangyou Bio-Pharmaceutical Co., Ltd. under fasting and postprandial conditions.
Olmesartan medoxomil and amlodipine tablets (test preparation, strength: 20 mg/5 mg) or licensed and produced by Daiichi Sankyo Europe GmbH
Pharmacokinetic characteristics, evaluation of the produced olmesartan medoxomil and amlodipine tablets (reference preparation, trade name: Sevikar®, strength: 20 mg/5 mg)
The bioequivalence and safety of the two preparations provide the basis for the registration application of the test preparation.
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.