/ CompletedNot Applicable 一项随机、开放、四周期、完全重复交叉、空腹给药临床研究，评价艾普拉唑肠溶片与壹丽安在中国健康成年参与者中的生物等效性
[Translation] A randomized, open-label, four-period, completely repeated crossover, fasting-administered clinical study to evaluate the bioequivalence of ilaprazole enteric-coated tablets and iliane in healthy Chinese adult participants
主要目的：
以浙江美迪深生物医药有限公司委托以岭万洲国际制药有限公司生产的艾普拉唑肠溶片（5mg）为受试制剂，按生物等效性试验的有关规定，与丽珠集团丽珠制药厂持有的艾普拉唑肠溶片（商品名：壹丽安，规格：5mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹条件下单次给药的生物等效性。
次要目的：
评估单剂口服受试制剂（艾普拉唑肠溶片，T）和参比制剂（壹丽安，R）在中国健康成年参与者中的安全性。
[Translation] Main purpose:
The bioequivalence test was conducted using ilaprazole enteric-coated tablets (5 mg) produced by Yiling Wanzhou International Pharmaceutical Co., Ltd. and commissioned by Zhejiang Medishen Biopharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of the bioequivalence test, the ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5 mg) held by Livzon Pharmaceutical Factory of Livzon Group were used as the reference preparation to compare the bioequivalence of the two preparations under fasting conditions after a single dose.
Secondary purpose:
To evaluate the safety of a single oral dose of the test preparation (ilaprazole enteric-coated tablets, T) and the reference preparation (Yilian, R) in healthy adult participants in China.
/ CompletedNot Applicable 一项随机、开放、四周期、完全重复交叉、空腹和餐后给药临床研究，评价艾普拉唑肠溶片与壹丽安在中国健康成年受试者中的生物等效性
[Translation] A randomized, open-label, four-period, completely repeated crossover, fasting and fed administration clinical study to evaluate the bioequivalence of ilaprazole enteric-coated tablets and iliane in healthy Chinese adult subjects
主要目的：以浙江美迪深生物医药有限公司持有的艾普拉唑肠溶片（5mg）为受试制剂，按生物等效性试验的有关规定，与丽珠集团丽珠制药厂持有的艾普拉唑肠溶片（商品名：壹丽安，规格：5mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹和餐后条件下单次给药的生物等效性。
次要目的：评估单剂口服受试制剂（艾普拉唑肠溶片，T）和参比制剂（壹丽安，R）在中国健康成年受试者中的安全性。
[Translation] Primary objective: To conduct a bioequivalence study using ilaprazole enteric-coated tablets (5 mg) held by Zhejiang Medishen Biopharmaceutical Co., Ltd. as the test preparation and ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5 mg) held by Livzon Pharmaceutical Factory of Livzon Group as the reference preparation according to the relevant provisions of the bioequivalence study, and to compare the bioequivalence of the two preparations under fasting and postprandial conditions after a single dose.
Secondary objective: To evaluate the safety of a single oral dose of the test preparation (ilaprazole enteric-coated tablets, T) and the reference preparation (Yilian, R) in healthy adult subjects in China.
/ CompletedNot Applicable 环孢素软胶囊在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of cyclosporine soft capsules in Chinese healthy volunteers under fasting conditions
主要研究目的：按有关生物等效性试验的规定，选择Novartis Pharma Schweiz AG为持证商的环孢素软胶囊（商品名：Sandimmun Neoral（新山地明），规格：25mg）为参比制剂，对浙江美迪深生物医药有限公司提供的受试制剂环孢素软胶囊（规格：25mg）进行空腹给药条件下的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环孢素软胶囊（规格：25mg）和参比制剂环孢素软胶囊（商品名：Sandimmun Neoral（新山地明），规格：25mg）的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, cyclosporine soft capsules (trade name: Sandimmun Neoral, specification: 25mg) with Novartis Pharma Schweiz AG as the licensee were selected as the reference preparation, and the test preparation cyclosporine soft capsules (specification: 25mg) provided by Zhejiang Medishen Biopharmaceutical Co., Ltd. were subjected to human bioequivalence test under fasting conditions, 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 conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation cyclosporine soft capsules (specification: 25mg) and the reference preparation cyclosporine soft capsules (trade name: Sandimmun Neoral, specification: 25mg) by healthy volunteers.
100 Clinical Results associated with Zhejiang Meidishen Biomedical Co., Ltd.
0 Patents (Medical) associated with Zhejiang Meidishen Biomedical Co., Ltd.
100 Deals associated with Zhejiang Meidishen Biomedical Co., Ltd.
100 Translational Medicine associated with Zhejiang Meidishen Biomedical Co., Ltd.
