/ Active, not recruitingNot Applicable 环丝氨酸胶囊在健康受试者中空腹给药条件下随机、开放、单剂量、两制剂、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of cycloserine capsules in healthy subjects under fasting conditions
主要目的：考察中国健康受试者在空腹条件下单次口服由浙江众延医药科技有限公司持有，浙江赛默制药有限公司生产的环丝氨酸胶囊（规格：250mg）与Meiji Seika ファルマ株式会社持证的环丝氨酸胶囊（规格：250mg）后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：评价单剂量口服环丝氨酸胶囊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 cycloserine capsules (specification: 250 mg) owned by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. and produced by Zhejiang Thermo Pharmaceutical Co., Ltd. and cycloserine capsules (specification: 250 mg) certified by Meiji Seika ファルマ Co., Ltd. in healthy Chinese subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test and reference preparations of cycloserine capsules in healthy Chinese subjects after a single oral administration.
/ CompletedNot 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.
/ CompletedNot 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.
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
