比索洛尔氨氯地平片在健康受试者中随机、开放、单剂量、两制剂、自身交叉对照空腹及餐后状态下的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-formulation, self-crossover controlled bioequivalence study of bisoprolol and amlodipine tablets in healthy subjects under fasting and fed conditions
主要目的：研究空腹及餐后状态下单次口服受试制剂比索洛尔氨氯地平片（规格：富马酸比索洛尔5mg与苯磺酸氨氯地平（按氨氯地平计）5mg，浙江百代医药科技有限公司研制，浙江赛默制药有限公司生产）与参比制剂比索洛尔氨氯地平片（商品名：Concor AM®/康忻安®，规格：富马酸比索洛尔5mg与苯磺酸氨氯地平（按氨氯地平计）5mg，Merck Kft持证，Egis Pharmaceuticals PLC生产）在健康成年受试者体内的药代动力学，评价空腹及餐后状态下口服两种制剂的生物等效性。
次要目的：研究受试制剂比索洛尔氨氯地平片和参比制剂比索洛尔氨氯地平片在健康成年受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), developed by Zhejiang Baidai Pharmaceutical Technology Co., Ltd. and produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation bisoprolol amlodipine tablets (trade name: Concor AM®/Kangxinan®, specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), licensed by Merck Kft, produced by Egis Pharmaceuticals PLC) in healthy adult subjects after a single oral administration in the fasting and postprandial state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting and postprandial state.
Secondary objective: To study the safety of the test preparation bisoprolol amlodipine tablets and the reference preparation bisoprolol amlodipine tablets in healthy adult subjects.
随机、开放、两制剂、两序列、两周期、自身交叉对照设计，评价中国健康受试者在空腹及餐后状态下单次口服环丝氨酸胶囊后的生物等效性正式试验
[Translation] A randomized, open-label, two-dose, two-sequence, two-period, self-crossover controlled study to evaluate the bioequivalence of a single oral dose of cycloserine capsules in Chinese healthy subjects in the fasting and fed state
主要目的：以浙江百代医药科技有限公司提供的环丝氨酸胶囊为受试制剂；并以Meiji Seikaファルマ株式会社的环丝氨酸胶囊为参比制剂，进行人体相对生物利用度和生物等效性评价。
[Translation] Main purpose: To evaluate the relative bioavailability and bioequivalence of cycloserine capsules provided by Zhejiang EMI Pharmaceutical Technology Co., Ltd. as the test preparation and cycloserine capsules produced by Meiji Seika Fluma Co., Ltd. as the reference preparation.
洛索洛芬钠细粒剂在健康受试者中随机、开放、两制剂、单次给药、双交叉空腹和餐后状态下的生物等效性研究
[Translation] A randomized, open-label, two-dose, single-dose, double-crossover bioequivalence study of loxoprofen sodium fine granules in healthy subjects under fasting and fed conditions
主要目的：研究空腹/餐后状态下单次口服受试制剂洛索洛芬钠细粒剂（规格：60mg，浙江赛默制药有限公司生产）与参比制剂洛索洛芬钠细粒剂（规格：10%（1g含无水物100mg）；第一三共株式会社生产）在健康成年受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。
[Translation] Main objective: To study the pharmacokinetics of the test preparation, loxoprofen sodium fine granules (specification: 60 mg, produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation, loxoprofen sodium fine granules (specification: 10% (1 g contains 100 mg of anhydrous substance); produced by Daiichi Sankyo Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting/fed state.
100 Clinical Results associated with Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.
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