/ Active, not recruitingNot Applicable 比索洛尔氨氯地平片在中国健康参与者中的一项单中心、随机、开放、空腹/餐后条件下单次给药、两制剂、两周期交叉的生物等效性试验
[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of bisoprolol and amlodipine tablets in healthy Chinese participants under fasting/fed conditions
主要研究目的：考察单次口服（空腹/餐后）受试制剂比索洛尔氨氯地平片和参比制剂比索洛尔氨氯地平片，在中国成年健康参与者体内的药代动力学特征，评估空腹/餐后条件下分别口服两种制剂的生物等效性。
次要研究目的：评价受试制剂和参比制剂单次口服（空腹/餐后）在中国成年健康参与者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of the test preparation bisoprolol amlodipine tablets and the reference preparation bisoprolol amlodipine tablets in healthy adult Chinese participants after a single oral administration (fasting/postprandial), and to evaluate the bioequivalence of the two preparations after oral administration under fasting/postprandial conditions.
Secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy adult Chinese participants after a single oral administration (fasting/postprandial).
/ CompletedNot Applicable 琥珀酸去甲文拉法辛缓释片在中国成年健康受试者中随机、开放、两制剂、两周期生物等效性研究（正式试验）
[Translation] A randomized, open-label, two-dose, two-period bioequivalence study of desvenlafaxine succinate extended-release tablets in healthy adult Chinese subjects (formal trial)
主要目的：健康成年受试者空腹和餐后口服单剂量琥珀酸去甲文拉法辛缓释片受试制剂与参比制剂后，以药代动力学参数为终点评价指标，按照生物等效性试验的有关规定，评价福建瑞泰来医药科技有限公司生产的琥珀酸去甲文拉法辛缓释片是否与Wyeth Pharmaceticals Inc.生产的原研琥珀酸去甲文拉法辛缓释片（参比制剂，持证商：PF Prism CV，商品名：Pristiq®，规格：50mg）具有生物等效性。 次要目的： 观察受试制剂琥珀酸去甲文拉法辛缓释片和参比制剂琥珀酸去甲文拉法辛缓释片（商品名：Pristiq®）在健康受试者中 的安全性。
[Translation] Primary objective: After a single oral dose of the test and reference desvenlafaxine succinate extended-release tablets was administered to healthy adult subjects on an empty stomach or after a meal, the pharmacokinetic parameters were used as the endpoint evaluation indicators. According to the relevant provisions of the bioequivalence test, the desvenlafaxine succinate extended-release tablets produced by Fujian Ruitailai Pharmaceutical Technology Co., Ltd. were evaluated to be bioequivalent to the original desvenlafaxine succinate extended-release tablets (reference preparation, licensee: PF Prism CV, trade name: Pristiq®, specification: 50 mg) produced by Wyeth Pharmaceticals Inc. Secondary objective: To observe the safety of the test desvenlafaxine succinate extended-release tablets and the reference desvenlafaxine succinate extended-release tablets (trade name: Pristiq®) in healthy subjects.
/ CompletedNot Applicable 熊去氧胆酸胶囊在空腹及餐后条件下的人体生物等效性研究
[Translation] Study on the bioequivalence of ursodeoxycholic acid capsules in fasting and fed subjects
采用随机、开放、两周期交叉、单剂量给药设计比较空腹和餐后给药条件下，福建瑞泰来医药科技有限公司委托福建广生堂药业股份有限公司生产的熊去氧胆酸胶囊（250 mg）与Losan Pharma GmbH 生产的熊去氧胆酸胶囊（商品名：优思弗®，规格：250 mg）在中国健康人群吸收程度和吸收速度的差异，并评价福建瑞泰来医药科技有限公司委托福建广生堂药业股份有限公司的熊去氧胆酸胶囊的安全性。
[Translation] A randomized, open, two-period crossover, single-dose design was used to compare the differences in absorption extent and rate of ursodeoxycholic acid capsules (250 mg) produced by Fujian Ruitailai Pharmaceutical Technology Co., Ltd. and produced by Fujian Guangshengtang Pharmaceutical Co., Ltd. and ursodeoxycholic acid capsules (trade name: Ursofol®, specification: 250 mg) produced by Losan Pharma GmbH in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of ursodeoxycholic acid capsules produced by Fujian Guangshengtang Pharmaceutical Co., Ltd. commissioned by Fujian Ruitailai Pharmaceutical Technology Co., Ltd.
100 Clinical Results associated with Fujian Reallion Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Fujian Reallion Pharmaceutical Technology Co., Ltd.
100 Deals associated with Fujian Reallion Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Fujian Reallion Pharmaceutical Technology Co., Ltd.
