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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date27 Oct 2006 |
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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 |
Target- |
Mechanism- |
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Active Indication- |
Inactive Indication- |
Drug Highest PhaseIND Application |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ CompletedNot Applicable 健康受试者在空腹及餐后状态下单次口服美阿沙坦钾片的人体生物等效性试验
[Translation] Bioequivalence study of single oral administration of mesartan potassium tablets in healthy subjects under fasting and fed conditions
(1)主要目的:以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定南京正科医药股份有限公司研制的美阿沙坦钾片给药后血浆中的活性代谢物阿齐沙坦在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以Takeda Pharma A/S 持证,Takeda Ireland Ltd.生产的美阿沙坦钾片【商品名:易达比(EDARBI)®,规格:按美阿沙坦(C30H24N4O8)计80 mg】为参比,评价制剂间的生物等效性。(2)次要目的:观察美阿沙坦钾片在中国健康受试者中的安全性。
[Translation] (1) Primary objective: To determine the time course of plasma concentration of the active metabolite azilsartan in healthy subjects after administration of acesartan potassium tablets developed by Nanjing Zhengke Pharmaceutical Co., Ltd. using a self-crossover design, and to estimate the corresponding pharmacokinetic parameters. The acesartan potassium tablets (trade name: EDARBI®, specification: 80 mg based on acesartan (C30H24N4O8)) produced by Takeda Pharma A/S and Takeda Ireland Ltd. were used as reference to evaluate the bioequivalence between the two preparations. (2) Secondary objective: To observe the safety of acesartan potassium tablets in healthy Chinese subjects.
/ CompletedNot Applicable 健康受试者在空腹及餐后状态下单次口服巴瑞替尼片的人体生物等效性试验
[Translation] Human bioequivalence study of a single oral dose of baricitinib tablets in healthy subjects in the fasting and fed state
(1)主要目的:以南京正科医药股份有限公司生产的巴瑞替尼片为受试制剂(T),以Eli Lilly Nederland B.V.持证的巴瑞替尼片(商品名:艾乐明® OLUMIANT®)为参比制剂(R),评估健康受试者在空腹及餐后状态下单次口服受试制剂和参比制剂的药代动力学特征,评价两种制剂的生物等效性。
(2)次要目的:评估受试制剂和参比制剂在健康受试者中的安全性。
[Translation] (1) Primary objective: To evaluate the pharmacokinetic characteristics of the test and reference preparations after a single oral administration in healthy subjects in the fasting and fed state, using baricitinib tablets produced by Nanjing Zhengke Pharmaceutical Co., Ltd. as the test preparation (T) and baricitinib tablets (trade name: OLUMIANT®) licensed by Eli Lilly Nederland B.V. as the reference preparation (R), and to evaluate the bioequivalence of the two preparations.
(2) Secondary objective: To evaluate the safety of the test and reference preparations in healthy subjects.
盐酸毛果芸香碱滴眼液在老视患者中随机、双盲、单次和多次给药的药代动力学研究
[Translation] A randomized, double-blind, single-dose and multiple-dose pharmacokinetic study of pilocarpine hydrochloride eye drops in presbyopic patients
主要研究目的:评价盐酸毛果芸香碱滴眼液受试制剂与参比制剂盐酸毛果芸香碱滴眼液(Vuity)的药代动力学特征。
次要研究目的:考察受试制剂和参比制剂在受试者给药后的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetic characteristics of the test preparation of pilocarpine hydrochloride eye drops and the reference preparation of pilocarpine hydrochloride eye drops (Vuity).
The secondary purpose of the study is to investigate the safety of the test preparation and the reference preparation after administration to the subjects.
100 Clinical Results associated with Nanjing Zenkom Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Nanjing Zenkom Pharmaceutical Co., Ltd.
100 Deals associated with Nanjing Zenkom Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Nanjing Zenkom Pharmaceutical Co., Ltd.