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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.South Korea |
First Approval Date31 Jan 2013 |
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MechanismL-type calcium channel blockers [+1] |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ CompletedNot Applicable 盐酸美金刚口崩片在中国健康受试者中的生物等效性研究
[Translation] Bioequivalence study of memantine hydrochloride orodisintegrating tablets in Chinese healthy subjects
主要研究目的:研究空腹/餐后状态下口服受试制剂盐酸美金刚口崩片(规格:20mg,江西施美药业股份有限公司生产)与参比制剂盐酸美金刚口崩片(商品名:Memary;规格:20mg,第一三共株式会社生产)在中国健康成年受试者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸美金刚口崩片和参比制剂Memary在中国健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation memantine hydrochloride orodisintegrating tablets (specification: 20 mg, produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation memantine hydrochloride orodisintegrating tablets (trade name: Memary; specification: 20 mg, produced by Daiichi Sankyo Co., Ltd.) in healthy Chinese adult subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose of the study: to evaluate the safety of the test preparation memantine hydrochloride orodisintegrating tablets and the reference preparation Memary in healthy Chinese adult subjects.
/ CompletedNot Applicable 沙库巴曲缬沙坦钠片在中国健康受试者中的生物等效性研究
[Translation] Bioequivalence study of sacubitril-valsartan sodium tablets in Chinese healthy subjects
主要研究目的:健康受试者空腹或餐后状态下,单次口服江西施美药业股份有限公司生产的受试制剂沙库巴曲缬沙坦钠片(规格:以沙库巴曲缬沙坦计200mg)或Novartis Singapore Pharmaceutical Manufacturing Private Ltd.生产的参比制剂沙库巴曲缬沙坦钠片(商品名:诺欣妥;规格:以沙库巴曲缬沙坦计200mg),分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。次要研究目的:考察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study is to examine the pharmacokinetic parameters of the test preparation and the reference preparation in the fasting or postprandial state in healthy subjects by taking a single oral dose of the test preparation Sacubitril-Valsartan Sodium Tablets (Specification: 200 mg based on Sacubitril-Valsartan) produced by Jiangxi Shimei Pharmaceutical Co., Ltd. or the reference preparation Sacubitril-Valsartan Sodium Tablets (trade name: Nuxintu; Specification: 200 mg based on Sacubitril-Valsartan) produced by Novartis Singapore Pharmaceutical Manufacturing Private Ltd., respectively, and evaluate the bioequivalence of the two preparations. The secondary purpose of the study is to examine the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 磷酸奥司他韦颗粒在中国健康受试者中的生物等效性研究
[Translation] Bioequivalence study of oseltamivir phosphate granules in Chinese healthy subjects
主要研究目的:研究空腹/餐后状态下口服受试制剂磷酸奥司他韦颗粒(规格:0.9g(按C16H28N2O4计),江西施美药业股份有限公司生产)与参比制剂磷酸奥司他韦干糖浆(商品名:Tamiflu ;规格:3%(30mg/g,30g),中外製薬株式会社持证)在中国健康成年受试者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂磷酸奥司他韦颗粒和参比制剂Tamiflu 在中国健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation oseltamivir phosphate granules (specification: 0.9g (calculated as C16H28N2O4), produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation oseltamivir phosphate dry syrup (trade name: Tamiflu; specification: 3% (30mg/g, 30g), certified by Chugai Pharmaceutical Co., Ltd.) in healthy adult Chinese subjects when taken orally in the fasting/fed state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting/fed state.
Secondary study objective: To evaluate the safety of the test formulation oseltamivir phosphate granules and the reference formulation Tamiflu in healthy adult subjects in China.
100 Clinical Results associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
100 Deals associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangxi Shimei Pharmaceutical Co., Ltd.