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MechanismTandem pore domain potassium channels inhibitors [+1] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date30 Sep 2002 |
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Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
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[Translation] Human pharmacokinetic study of RHYK2008
主要目的:在健康受试者体内,空腹条件下,以Recordati S.P.A.持有的盐酸乐卡地平片(商品名:Zanidip®;规格:10 mg)为对照药,研究石家庄科仁医药科技有限公司研发的RHYK2008(规格:10 mg;试验药)的人体药代动力学,为后续临床试验提供依据。
次要目的:观察健康受试者空腹口服试验药、对照药的安全性。
[Translation] Main purpose: In healthy subjects, under fasting conditions, use Lercanidipine Hydrochloride Tablets (trade name: Zanidip®; Specification: 10 mg) held by Recordati S.P.A. as the control drug to study the drug developed by Shijiazhuang Keren Pharmaceutical Technology Co., Ltd. The human pharmacokinetics of RHYK2008 (specification: 10 mg; experimental drug) will provide a basis for subsequent clinical trials.
Secondary purpose: To observe the safety of healthy subjects taking the test drug and control drug orally on an empty stomach.
[Translation] Bioequivalence Test of Entofloxacin Hydrochloride Tablets
主要目的:在健康受试者体内,分别在空腹和餐后状态下,以安徽环球药业股份有限公司持有的盐酸安妥沙星片(规格:0.1 g(以C18H21FN4O4 计);商品名:优朋®)为参比制剂,研究仁合益康集团有限公司持有的盐酸安妥沙星片(规格:0.1 g(以C18H21FN4O4 计);受试制剂)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: In healthy subjects, under fasting and postprandial conditions, Antofloxacin Hydrochloride Tablets held by Anhui Global Pharmaceutical Co., Ltd. (Specification: 0.1 g (calculated as C18H21FN4O4); Trade Name: Excellent Peng®) is used as the reference preparation to study the pharmacokinetics of Antofloxacin Hydrochloride Tablets (specification: 0.1 g (calculated as C18H21FN4O4); test preparation) held by Renhe Yikang Group Co., Ltd., and evaluate the relationship between the test preparation and Whether the reference product is bioequivalent.
Secondary purpose: To observe the safety of test preparation and reference preparation in healthy subjects.
[Translation] Bioequivalence test of lamotrigine dispersible tablets
主要目的:在健康受试者体内,在空腹和餐后条件下,以The Wellcome Foundation Limited公司持有的拉莫三嗪分散片(规格:50 mg,商品名:利必通®)为参比制剂,仁合益康集团有限公司持有的拉莫三嗪分散片(规格:50 mg)为受试制剂,研究两制剂的药代动力学,评价两制剂是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性
[Translation] Main purpose: In healthy subjects, under fasting and postprandial conditions, lamotrigine dispersible tablets held by The Wellcome Foundation Limited (specification: 50 mg, trade name: Labiton®) are used as a reference The preparation, lamotrigine dispersible tablets (specification: 50 mg) held by Renhe Yikang Group Co., Ltd. is the test preparation. The pharmacokinetics of the two preparations are studied and whether the two preparations are bioequivalent.
Secondary purpose: To observe the safety of test and reference preparations in healthy subjects
100 Clinical Results associated with Renhe Yikang Group Co., Ltd.
0 Patents (Medical) associated with Renhe Yikang Group Co., Ltd.
100 Deals associated with Renhe Yikang Group Co., Ltd.
100 Translational Medicine associated with Renhe Yikang Group Co., Ltd.