/ CompletedNot Applicable [Translation] Bioequivalence test of cefcapine hydrochloride granules
主要研究目的
评价中国健康成年试验参与者空腹及餐后条件下单次单剂量口服盐酸头孢卡品酯颗粒受试制剂[规格:50mg(按C17H19N5O6S2计),申办者:广州仁恒医药科技股份有限公司]和参比制剂[规格:50mg(按C17H19N5O6S2计),持证商:SHIONOGI & Co., LTD.]后的药代动力学特点和生物等效性。
次要研究目的
研究盐酸头孢卡品酯颗粒受试制剂[规格:50mg(按C17H19N5O6S2计)]和参比制剂[规格:50mg(按C17H19N5O6S2计)]在中国健康成年试验参与者中的安全性和适口性。
[Translation] Primary Objective: To evaluate the pharmacokinetic characteristics and bioequivalence of a single oral dose of cefoperazone hydrochloride granules (test formulation: 50 mg (C17H19N5O6S2), Sponsor: Guangzhou Renheng Pharmaceutical Technology Co., Ltd.) and reference formulation (C17H19N5O6S2, Licensee: SHIONOGI & Co., LTD.) in healthy adult Chinese participants under fasting and postprandial conditions.
Secondary Objective: To investigate the safety and palatability of cefoperazone hydrochloride granules (test formulation: 50 mg (C17H19N5O6S2)) and reference formulation (C17H19N5O6S2) in healthy adult Chinese participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of salmon calcitonin injection in healthy volunteers
研究健康受试者在皮下注射给药方式情况下单次给予由广州仁恒医药科技股份有限公司提供的鲑降钙素注射液(受试制剂T,规格:1mL:50IU)或给予由Future Health Pharma GmbH持证的鲑降钙素注射液(参比制剂R,商品名:Miacalcin®,规格:1mL:50IU)的药动学特征,评价两制剂间的生物等效性及安全性,为该受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single subcutaneous administration of salmon calcitonin injection (test preparation T, strength: 1mL:50IU) provided by Guangzhou Yanlord Pharmaceuticals Co., Ltd. or salmon calcitonin injection (reference preparation R, trade name: Miacalcin®, strength: 1mL:50IU) certified by Future Health Pharma GmbH to healthy subjects, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
/ CompletedNot Applicable [Translation] Bioequivalence study of salmon calcitonin injection in humans
主要目的:研究健康受试者在皮下注射给药方式情况下单次给予由广州仁恒医药科技股份有限公司提供的鲑降钙素注射液(受试制剂T,规格:1mL:50IU)或给予由Future Health Pharma GmbH持证的鲑降钙素注射液(参比制剂R,商品名:Miacalcin®,规格:1mL:50IU)的药动学特征,评价两制剂间的生物等效性及安全性,为该受试制剂的注册申请提供依据。
次要目的:探索给予相同剂量的鲑降钙素注射液(规格:1mL:50IU)受试制剂或参比制剂的情况下,Ⅰ型胶原交联C-末端肽(β-CTx)的变化情况。
[Translation] Primary objective: To study the pharmacokinetic characteristics of salmon calcitonin injection (test preparation T, specification: 1mL: 50IU) provided by Guangzhou Yanheng Pharmaceutical Technology Co., Ltd. or salmon calcitonin injection (reference preparation R, trade name: Miacalcin®, specification: 1mL: 50IU) certified by Future Health Pharma GmbH when administered to healthy subjects by subcutaneous injection, to evaluate the bioequivalence and safety between the two preparations, and to provide a basis for the registration application of the test preparation.
Secondary objective: To explore the changes in type I collagen cross-linked C-terminal peptide (β-CTx) when the same dose of salmon calcitonin injection (specification: 1mL: 50IU) test preparation or reference preparation is administered.
100 Clinical Results associated with Renheng Pharm Ltd.
0 Patents (Medical) associated with Renheng Pharm Ltd.
100 Deals associated with Renheng Pharm Ltd.
100 Translational Medicine associated with Renheng Pharm Ltd.