乙酰半胱氨酸颗粒在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of acetylcysteine granules in Chinese healthy subjects under fasting and fed conditions
验的规定，选择海南赞邦制药有限公司为持证商的乙酰半胱氨酸颗粒（商品名：富露施®，规格：0.2g）为参比制剂，对石家庄市华新药业有限责任公司生产，浙江众延医药科技有限公司持证的受试制剂乙酰半胱氨酸颗粒（规格：0.2g）进行空腹和餐后给药人体生物等效主要研究目的：按有关生物等效性试性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的：观察健康志愿受试者口服受试制剂乙酰半胱氨酸颗粒（规格：0.2g）和参比制剂乙酰半胱氨酸颗粒（商品名：富露施®，规格：0.2g）的安全性。
[Translation] According to the provisions of the bioequivalence test, acetylcysteine granules (trade name: Fulushi®, specification: 0.2g) produced by Hainan Zanbang Pharmaceutical Co., Ltd. as a licensee were selected as the reference preparation, and the test preparation acetylcysteine granules (specification: 0.2g) produced by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. and certified by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. were tested for fasting and postprandial human bioequivalence. The main research purpose: According to the relevant bioequivalence test, compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: Observe the safety of oral administration of the test preparation acetylcysteine granules (specification: 0.2g) and the reference preparation acetylcysteine granules (trade name: Fulushi®, specification: 0.2g) by healthy volunteers.
[Translation] Study on the bioequivalence of clopidogrel bisulfate tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服浙江众延医药科技有限公司持证、青岛黄海制药有限责任公司生产的硫酸氢氯吡格雷片（75 mg）的药代动力学特征；以Sanofi-aventis groupe持证、Sanofi Winthrop Industrie生产的硫酸氢氯吡格雷片（波立维®，75 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] This study aimed to study the pharmacokinetic characteristics of a single fasting and postprandial oral administration of clopidogrel bisulfate tablets (75 mg) licensed by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. and produced by Qingdao Huanghai Pharmaceutical Co., Ltd.; using clopidogrel bisulfate tablets (Plavix®, 75 mg) licensed by Sanofi-aventis groupe and produced by Sanofi Winthrop Industrie as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
西格列汀二甲双胍片(II)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of sitagliptin and metformin tablets (II) in Chinese healthy subjects under fasting and fed conditions
主要研究目的：按有关生物等效性试验的规定，选择MSD Pharma (Singapore) Pte.Ltd为持证商的西格列汀二甲双胍片(Ⅱ)（商品名：捷诺达；规格：50mg/850mg）为参比制剂，对青岛黄海制药有限责任公司生产、浙江众延医药科技有限公司提供的受试制剂西格列汀二甲双胍片(II)（规格：50mg/850mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的：观察健康志愿受试者口服受试制剂西格列汀二甲双胍片(II)（规格：50mg/850mg）和参比制剂西格列汀二甲双胍片(Ⅱ)（商品名：捷诺达；规格：50mg/850mg）的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, Sitagliptin Metformin Tablets (II) (trade name: Jeroda; specification: 50mg/850mg) with MSD Pharma (Singapore) Pte. Ltd as the licensee was selected as the reference preparation, and the test preparation Sitagliptin Metformin Tablets (II) (specification: 50mg/850mg) produced by Qingdao Huanghai Pharmaceutical Co., Ltd. and provided by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. was subjected to human bioequivalence test for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation Sitagliptin Metformin Tablets (II) (specification: 50mg/850mg) and the reference preparation Sitagliptin Metformin Tablets (II) (trade name: Jeroda; specification: 50mg/850mg) to healthy volunteers.
100 Clinical Results associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
0 Patents (Medical) associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
100 Deals associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
