/ RecruitingNot Applicable [Translation] Study on the bioequivalence of adecalcitol soft capsules 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研制、大连美创药业有限公司生产的艾地骨化醇软胶囊（0.75 μg）的药代动力学特征；以Fujieda Plant of Chugai Pharma Manufacturing Co.,Ltd生产的艾地骨化醇软胶囊（0.75 μg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-72，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 0.75 μg of idecalcitol soft capsules developed by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. and produced by Dalian Meichuang Pharmaceutical Co., Ltd.; using 0.75 μg of idecalcitol soft capsules produced by Fujieda Plant of Chugai Pharma Manufacturing Co., Ltd as the reference preparation, to compare the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
/ Active, not recruitingNot Applicable 吡格列酮二甲双胍片在健康受试者中空腹/餐后、单剂量口服、随机、开放、两制剂、两周期生物等效性研究
[Translation] A fasting/fed, single-dose oral, randomized, open-label, two-formulation, two-period bioequivalence study of pioglitazone and metformin tablets in healthy subjects
主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服浙江众延医药科技有限公司研制和提供的吡格列酮二甲双胍片（规格：15mg/500mg/片）与武田テバ薬品株式会社生产的吡格列酮二甲双胍片（规格：15mg/500mg/片）的体内药代动力学特征，评价两制剂的生物等效性。
次要目的：评价单剂量口服吡格列酮二甲双胍片（规格：15mg/500mg/片）受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) developed and provided by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. and pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) produced by Takeda Teba Pharmaceutical Co., Ltd. in Chinese healthy subjects after single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation and reference preparation of single oral pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) in Chinese healthy subjects.
/ CompletedNot Applicable 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.
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
