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MechanismCYP17A1 inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date28 Apr 2011 |
Target- |
Mechanism- |
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Active Indication- |
Inactive Indication- |
Drug Highest PhaseIND Application |
First Approval Ctry. / Loc.- |
First Approval Date- |
美阿沙坦钾片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of Asartan potassium tablets in humans under fasting and fed conditions
本研究考察健康受试者在空腹及餐后条件下,单次口服由湖南慧泽生物医药科技有限公司提供的美阿沙坦钾片(受试制剂,规格:80mg)或由Takeda Pharma A/S持证的美阿沙坦钾片(参比制剂,商品名:易达比,规格:80mg)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] This study investigated the pharmacokinetic characteristics of a single oral dose of Asartan Potassium Tablets (test preparation, strength: 80 mg) provided by Hunan Huize Biopharmaceutical Technology Co., Ltd. or Asartan Potassium Tablets (reference preparation, trade name: Edabi, strength: 80 mg) certified by Takeda Pharma A/S in healthy subjects under fasting and postprandial conditions, evaluated the bioequivalence and safety of the two preparations, and provided a basis for the registration application of the test preparation.
二甲双胍恩格列净片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of metformin and empagliflozin tablets in humans under fasting and fed conditions
研究健康受试者在空腹及餐后状态下,单次口服由湖南慧泽生物医药科技有限公司提供的二甲双胍恩格列净片(受试制剂,规格:每片含盐酸二甲双胍500mg与恩格列净5mg)与相同状态下单次口服由Boehringer Ingelheim Pharmaceuticals Inc持证的二甲双胍恩格列净片(参比制剂,商品名:Synjardy,规格:每片含盐酸二甲双胍500mg与恩格列净5mg)的药动学特征,评价两制剂间的生物等效性和安全性,为该受试制剂注册申请提供依据。
[Translation] To study the pharmacokinetic characteristics of a single oral administration of metformin empagliflozin tablets (test preparation, specification: each tablet contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin) provided by Hunan Huize Biotechnology Co., Ltd. in healthy subjects under fasting and postprandial conditions and a single oral administration of metformin empagliflozin tablets (reference preparation, trade name: Synjardy, specification: each tablet contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin) certified by Boehringer Ingelheim Pharmaceuticals Inc. under the same conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
[Translation] Bioequivalence study of mesalazine enteric-coated tablets in humans
本研究考察健康受试者在空腹及餐后条件下,单次口服1片由湖南慧泽生物医药科技有限公司提供的受试制剂美沙拉秦肠溶片(规格:0.5g)与相同条件下单次口服1片由Losan Pharma GmbH生产(Dr. Falk Pharma GmbH持证)的参比制剂美沙拉秦肠溶片(商品名:Salofalk,规格:0.5g)的药动学特征,评价两制剂间的生物等效性和安全性,为该受试制剂注册申请提供依据。
[Translation] This study investigated the pharmacokinetic characteristics of a single oral dose of the test preparation Mesalazine Enteric-coated Tablets (specification: 0.5 g) provided by Hunan Huize Biopharmaceutical Technology Co., Ltd. in healthy subjects under fasting and postprandial conditions, compared with a single oral dose of the reference preparation Mesalazine Enteric-coated Tablets (trade name: Salofalk, specification: 0.5 g) produced by Losan Pharma GmbH (certified by Dr. Falk Pharma GmbH) under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
100 Clinical Results associated with Hunan Huize Biomedical Technology Co., Ltd.
0 Patents (Medical) associated with Hunan Huize Biomedical Technology Co., Ltd.
100 Deals associated with Hunan Huize Biomedical Technology Co., Ltd.
100 Translational Medicine associated with Hunan Huize Biomedical Technology Co., Ltd.