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Mechanism5-HT1A receptor agonists [+5] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date30 Sep 2013 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date17 Dec 1999 |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Human Bioequivalence Test of Mesalazine Enteric-Coated Tablets under Fasting Condition
本研究考察健康受试者在空腹条件下,单次口服1片由华益泰康药业股份有限公司生产的受试制剂美沙拉秦肠溶片(规格:0.5g)与单次口服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,为该受试制剂注册申请提供依据。
次要研究目的
观察健康受试者单次口服1片受试制剂美沙拉秦肠溶片(规格:0.5g)与参比制剂美沙拉秦肠溶片(商品名:Salofalk®,规格:0.5g)的安全性。
[Translation] In this study, under fasting conditions, healthy subjects took one tablet of mesalazine enteric-coated tablets (specification: 0.5g) produced by Huayi Taikang Pharmaceutical Co., Ltd. Pharmacokinetic characteristics of the reference preparation Mesalazine Enteric-coated Tablets (trade name: Salofalk®, specification: 0.5g) produced by Losan Pharma GmbH (licensed by Dr. Falk Pharma GmbH), to evaluate the bioequivalence between the two preparations , to provide a basis for the registration application of the test preparation.
Secondary research purpose
To observe the safety of a single oral administration of the test preparation Mesalazine Enteric-coated Tablets (specification: 0.5g) and the reference preparation Mesalazine Enteric-coated Tablets (trade name: Salofalk®, specification: 0.5g) in healthy subjects .
[Translation] Human Bioequivalence Test of Agomelatine Tablets under Fasting Condition
本研究考察健康受试者在空腹条件下,单次口服由华益泰康药业股份有限公司生产的阿戈美拉汀片(受试制剂,规格:25 mg)或由Les Laboratoires Servier持证的阿戈美拉汀片(参比制剂,商品名:Valdoxan®,规格:25 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, under fasting conditions, healthy subjects took a single oral administration of agomelatine tablets (test preparation, specification: 25 mg) produced by Huayi Taikang Pharmaceutical Co., Ltd. or licensed by Les Laboratoires Servier. The pharmacokinetic characteristics of agomelatine tablets (reference preparation, trade name: Valdoxan®, strength: 25 mg) and the evaluation of the bioequivalence and safety of the two preparations provided a basis for the registration application of the test preparation.
[Translation] Human Bioequivalence Test of Mesalazine Enteric-Coated Tablets under Postprandial Conditions
本研究考察健康受试者餐后条件下,单次口服1片由华益泰康药业股份有限公司生产的受试制剂美沙拉秦肠溶片(规格:0.5g)与单次口服1片由Losan Pharman 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,为该受试制剂注册申请提供依据。
[Translation] In this study, under the postprandial condition of healthy volunteers, a single oral administration of a test preparation mesalazine enteric-coated tablet (specification: 0.5g) produced by Huayi Taikang Pharmaceutical Co., Ltd. Pharmacokinetic characteristics of the reference preparation Mesalazine Enteric-Coated Tablets (trade name: Salofalk®, specification: 0.5g) produced by Losan Pharma GmbH (certified by Dr. Falk Pharma GmbH), to evaluate the bioequivalence between the two preparations , to provide a basis for the registration application of the test preparation.
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