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Mechanism5-HT1A receptor agonists [+5] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date30 Sep 2013 |
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MechanismD2 receptor antagonists [+1] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Australia |
First Approval Date01 Feb 2002 |
/ CompletedNot Applicable [Translation] Bioequivalence study of trazodone hydrochloride sustained-release tablets in humans under fasting conditions
研究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提供的盐酸曲唑酮缓释片(受试制剂,规格:75mg)与相同条件下单次口服由AZ. Chim.Riun.Angelini Francesco Acraf S.P.A.持证的盐酸曲唑酮缓释片(参比制剂,商品名:Trittico®,规格:75mg)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] To study the pharmacokinetic characteristics of a single oral administration of trazodone hydrochloride sustained-release tablets (test preparation, specification: 75 mg) provided by Huayi Taikang Pharmaceutical Co., Ltd. under fasting conditions in healthy subjects and a single oral administration of trazodone hydrochloride sustained-release tablets (reference preparation, trade name: Trittico®, specification: 75 mg) certified by AZ. Chim. Riun. Angelini Francesco Acraf S.P.A. under the same conditions, to evaluate the bioequivalence between the two preparations and provide a basis for the registration application of the test preparation.
/ CompletedNot Applicable [Translation] Bioequivalence study of trazodone hydrochloride sustained-release tablets in humans under fed conditions
研究健康受试者在餐后条件下,单次口服由华益泰康药业股份有限公司提供的盐酸曲唑酮缓释片(受试制剂,规格:75mg)与相同条件下单次口服由AZ. Chim.Riun.Angelini Francesco Acraf S.P.A.持证的盐酸曲唑酮缓释片(参比制剂,商品名:Trittico®,规格:75mg)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] To study the pharmacokinetic characteristics of a single oral administration of trazodone hydrochloride sustained-release tablets (test preparation, specification: 75 mg) provided by Huayi Taikang Pharmaceutical Co., Ltd. under postprandial conditions in healthy subjects and a single oral administration of trazodone hydrochloride sustained-release tablets (reference preparation, trade name: Trittico®, specification: 75 mg) certified by AZ. Chim. Riun. Angelini Francesco Acraf S.P.A. under the same conditions, to evaluate the bioequivalence between the two preparations and provide a basis for the registration application of the test preparation.
/ CompletedNot Applicable [Translation] Bioequivalence study of mycophenolate sodium enteric-coated tablets in humans under fasting conditions
考察健康研究参与者在空腹条件下,单次口服由华益泰康药业股份有限公司提供的麦考酚钠肠溶片(受试制剂,规格:0.18g)与单次口服由Novartis Pharma GmbH持证的麦考酚钠肠溶片(参比制剂,商品名:Myfortic®,规格:180mg)的药代动力学特征,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 investigate the pharmacokinetic characteristics of healthy study participants after a single oral administration of mycophenolate sodium enteric-coated tablets (test preparation, specification: 0.18g) provided by Huayi Taikang Pharmaceutical Co., Ltd. and a single oral administration of mycophenolate sodium enteric-coated tablets (reference preparation, trade name: Myfortic®, specification: 180mg) certified by Novartis Pharma GmbH under fasting conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
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