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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date28 May 2001 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date23 Jun 1989 |
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Mechanism- |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CA |
First Approval Date01 Jan 1985 |
[Translation] Bioequivalence study of valacyclovir hydrochloride tablets in healthy subjects
以湖北科益药业股份有限公司提供的盐酸伐昔洛韦片(规格:0.5g)为受试制剂,The Wellcome Foundation Limited的盐酸伐昔洛韦片(商品名:Valtrex,维德思®,规格:0.5g)为参比制剂,按生物等效性试验的有关规定,比较两制剂在健康人体的药代动力学参数,考察两制剂的人体生物等效性。
[Translation] Valacyclovir hydrochloride tablets (specification: 0.5g) provided by Hubei Keyi Pharmaceutical Co., Ltd. were used as the test preparation, and valacyclovir hydrochloride tablets (trade name: Valtrex, Verdes®, The Wellcome Foundation Limited) were used as test preparations. Specification: 0.5g) is the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic parameters of the two preparations in healthy humans are compared, and the human bioequivalence of the two preparations is investigated.
[Translation] Bioequivalence study of acyclovir tablets in healthy subjects
主要研究目的
以湖北科益药业股份有限公司研制生产的阿昔洛韦片(规格:0.2g)为受试制剂,Glaxo Smithkline K.K.公司持证的阿昔洛韦片(商品名:Zovirax®,规格:0.2g)为参比制剂,比较两制剂在健康人体的药代动力学参数,评价两制剂在空腹及餐后两种状态下的人体生物等效性。
次要研究目的
观察受试制剂阿昔洛韦片和参比制剂阿昔洛韦片(Zovirax®)在健康受试者中的安全性。
[Translation] Main research purpose
Acyclovir tablets (specification: 0.2 g) developed and produced by Hubei Keyi Pharmaceutical Co., Ltd. were used as the test preparation, and acyclovir tablets (trade name: Zovirax®, specification: 0.2 g) were licensed by Glaxo Smithkline K.K. g) As a reference preparation, compare the pharmacokinetic parameters of the two preparations in healthy humans, and evaluate the human bioequivalence of the two preparations in fasting and postprandial states.
Secondary research purpose
To observe the safety of the test preparation Acyclovir Tablets and the reference preparation Acyclovir Tablets (Zovirax®) in healthy subjects.
100 Clinical Results associated with Hubei Keyi Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hubei Keyi Pharmaceutical Co., Ltd.
100 Deals associated with Hubei Keyi Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hubei Keyi Pharmaceutical Co., Ltd.