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Overview

主要目的：以广州市微生物研究所集团股份有限公司持有的麦考酚钠肠溶片为受试制剂（规格：0.18g），按生物等效性试验的有关规定，与Novartis Pharma GmbH持有的麦考酚钠肠溶片（商品名：Myfortic（米芙），规格180mg）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（麦考酚钠肠溶片，T）和参比制剂（商品名：Myfortic（米芙），R）在中国健康成年受试者中的安全性。

[Translation]

Main purpose: Using mycophenolate sodium enteric-coated tablets (specification: 0.18g) held by Guangzhou Institute of Microbiology Group Co., Ltd. as the test preparation, and mycophenolate sodium enteric-coated tablets (trade name: Myfortic, specification 180mg) held by Novartis Pharma GmbH as the reference preparation, a bioequivalence test was conducted according to the relevant provisions of the bioequivalence test to compare the bioequivalence of the two preparations under fasting conditions after a single dose. Secondary purpose: Evaluate the safety of a single oral dose of the test preparation (mycophenolate sodium enteric-coated tablets, T) and the reference preparation (trade name: Myfortic, R) in healthy adult subjects in China.

Start Date-

Sponsor / Collaborator

Guangzhou Microorganism Research Institute

CTR20233216 / Not yet recruitingNot Applicable

一项随机、开放、四周期、完全重复交叉设计评价中国健康受试者空腹和餐后单次口服麦考酚钠肠溶片的人体生物等效性试验

[Translation] A randomized, open-label, four-period, completely repeated crossover design study to evaluate the bioequivalence of fasting and fed single oral administration of mycophenolate sodium enteric-coated tablets in healthy Chinese subjects

主要目的：以广州市微生物研究所集团股份有限公司持有的麦考酚钠肠溶片为受试制剂（规格：0.18g），按生物等效性试验的有关规定，与 Novartis Pharma GmbH 持有的麦考酚钠肠溶片（商品名：Myfortic（米芙），规格 180mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹及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（麦考酚钠肠溶片，T）和参比制剂（商品名：Myfortic（米芙），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 mycophenolate sodium enteric-coated tablets (specification: 0.18 g) held by Guangzhou Institute of Microbiology Group Co., Ltd. as the test preparation (specification: 0.18 g) and mycophenolate sodium enteric-coated tablets (trade name: Myfortic, specification 180 mg) held by Novartis Pharma GmbH 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 (mycophenolate sodium enteric-coated tablets, T) and the reference preparation (trade name: Myfortic, R) in healthy adult subjects in China.

Start Date-

Sponsor / Collaborator

Guangzhou Microorganism Research Institute

CTR20232609 / TerminatedNot Applicable

一项随机、开放、四周期、完全重复交叉设计评价中国健康受试者空腹和餐后单次口服麦考酚钠肠溶片的人体生物等效性试验

[Translation] A randomized, open-label, four-period, completely repeated crossover design study to evaluate the bioequivalence of fasting and fed single oral administration of mycophenolate sodium enteric-coated tablets in healthy Chinese subjects

主要目的：以广州市微生物研究所集团股份有限公司持有的麦考酚钠肠溶片为受试制剂（规格：0.18g），按生物等效性试验的有关规定，与 Novartis Pharma GmbH 持有的麦考酚钠肠溶片（商品名：Myfortic（米芙），规格 180mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹及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（麦考酚钠肠溶片，T）和参比制剂（商品名：Myfortic（米芙），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 mycophenolate sodium enteric-coated tablets (specification: 0.18 g) held by Guangzhou Institute of Microbiology Group Co., Ltd. as the test preparation (specification: 0.18 g) and mycophenolate sodium enteric-coated tablets (trade name: Myfortic, specification 180 mg) held by Novartis Pharma GmbH 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 (mycophenolate sodium enteric-coated tablets, T) and the reference preparation (trade name: Myfortic, R) in healthy adult subjects in China.

Start Date-

Sponsor / Collaborator

Guangzhou Microorganism Research Institute

100 Clinical Results associated with Guangzhou Microorganism Research Institute

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0 Patents (Medical) associated with Guangzhou Microorganism Research Institute

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100 Deals associated with Guangzhou Microorganism Research Institute

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100 Translational Medicine associated with Guangzhou Microorganism Research Institute

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