/ Active, not recruitingNot Applicable [Translation] Study on the bioequivalence of levamlodipine besylate tablets in healthy volunteers
"主要研究目的
研究空腹和餐后状态下单次口服受试制剂苯磺酸左氨氯地平片（规格：5mg，浙江诺得药业有限公司提供）与参比制剂苯磺酸氨氯地平片（络活喜®；规格：10mg；持证商：晖致制药（大连）有限公司）在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后状态下，单次口服受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片（络活喜®）后的安全性。"
[Translation] "Main study objectives
To study the pharmacokinetics of the test preparation levamlodipine besylate tablets (specification: 5mg, provided by Zhejiang Nord Pharmaceutical Co., Ltd.) and the reference preparation amlodipine besylate tablets (Norvasc®; specification: 10mg; licensee: Huizhi Pharmaceutical (Dalian) Co., Ltd.) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary study objectives
To evaluate the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy Chinese subjects in the fasting and fed state after a single oral administration."
/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of metformin and empagliflozin tablets (Ⅰ) in human subjects
本试验旨在研究单次空腹和餐后口服浙江诺得药业有限公司研制、生产的二甲双胍恩格列净片（Ⅰ）（500 mg/5 mg）的药代动力学特征；以Boehringer Ingelheim Pharmaceuticals Inc持证、Boehringer Ingelheim Pharma GmbH & Co. KG生产的二甲双胍恩格列净片（Ⅰ）（Synjardy®，500 mg/5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察两制剂在健康研究参与者中的安全性。
[Translation] This study aims to study the pharmacokinetic characteristics of metformin empagliflozin tablets (I) (500 mg/5 mg) developed and produced by Zhejiang Nord Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using metformin empagliflozin tablets (I) (Synjardy®, 500 mg/5 mg) licensed by Boehringer Ingelheim Pharmaceuticals Inc and produced by Boehringer Ingelheim Pharma GmbH & Co. KG as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations in healthy study participants.
/ Active, not recruitingNot Applicable [Translation] Study on the bioequivalence of melogabalin besylate tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服浙江诺得药业有限公司研制、生产的苯磺酸美洛加巴林片（5 mg）的药代动力学特征；以第一三共株式会社持证、生产的苯磺酸美洛加巴林片（Tarlige®，5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。
[Translation] The aim of this study was to investigate the pharmacokinetic characteristics of melogabalin besylate tablets (5 mg) developed and produced by Zhejiang Nord Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using melogabalin besylate tablets (Tarlige®, 5 mg) licensed and produced by Daiichi Sankyo Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
100 Deals associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
