/ Active, not recruitingNot Applicable 双氯芬酸二乙胺乳胶剂在中国健康人群中外用条件下单次给药的人体生物等效性临床试验方案
[Translation] A human bioequivalence clinical trial protocol for a single-dose topical administration of diclofenac diethylamine emulsion in healthy Chinese people
主要目的:以持证商为GSK Consumer Healthcare Schweiz AG 的双氯芬酸二乙胺乳胶剂,规格:1%(20g:0.2g,以双氯芬酸钠计))为参比制剂,以青岛百洋制药有限公司研发的双氯芬酸二乙胺乳胶剂(1%(20g:0.2g,以双氯芬酸钠计))为受试制剂,评价两种制剂在中国健康受试者中外用条件下的生物等效性。
次要目的:1)评价受试制剂与参比制剂在中国健康受试者中的安全性;2)评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations under topical conditions in healthy Chinese subjects, using diclofenac diethylamine emulsion (specification: 1% (20g:0.2g, calculated as diclofenac sodium)) from GSK Consumer Healthcare Schweiz AG as the reference preparation and diclofenac diethylamine emulsion (1% (20g:0.2g, calculated as diclofenac sodium)) developed by Qingdao Baiyang Pharmaceutical Co., Ltd. as the test preparation.
Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects; 2) To evaluate the skin reactivity of the test preparation and the reference preparation in healthy Chinese subjects.
/ CompletedNot Applicable 艾司奥美拉唑镁肠溶胶囊在健康受试者中的人体生物等效性研究
[Translation] Human bioequivalence study of esomeprazole magnesium enteric-coated capsules in healthy volunteers
主要目的:本研究以青岛百洋制药有限公司生产的艾司奥美拉唑镁肠溶胶囊(规格:40mg)为受试制剂,以AstraZeneca Pharmaceuticals LP生产的艾司奥美拉唑镁肠溶胶囊(规格:40mg;Nexium®)为参比制剂进行生物等效性试验,评价受试制剂和参比制剂在空腹、空腹苹果酱撒布条件和餐后条件下给药时的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study used Esomeprazole Magnesium Enteric-coated Capsules (Specification: 40 mg) produced by Qingdao Baiyang Pharmaceutical Co., Ltd. as the test preparation and Esomeprazole Magnesium Enteric-coated Capsules (Specification: 40 mg; Nexium®) produced by AstraZeneca Pharmaceuticals LP as the reference preparation for bioequivalence testing to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting, fasting applesauce spreading conditions, and postprandial conditions.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 盐酸美金刚缓释胶囊在餐后条件下的随机、开放、平行设计的生物等效性研究
[Translation] A randomized, open-label, parallel-design bioequivalence study of memantine hydrochloride extended-release capsules under fed conditions
主要目的:证明正常健康成年受试者餐后服用受试制剂(T):盐酸美金刚缓释胶囊28mg 和参比制剂(R):NAMENDA XR®(盐酸美金刚)缓释胶囊28mg 的生物等效性。 次要目的:监测单次口服试验用药物的安全性和耐受性。
[Translation] Primary objective: To demonstrate the bioequivalence of the test formulation (T): memantine hydrochloride extended-release capsules 28 mg and the reference formulation (R): NAMENDA XR® (memantine hydrochloride) extended-release capsules 28 mg in normal healthy adult subjects after taking a meal. Secondary objective: To monitor the safety and tolerability of a single oral dose of the test drug.
100 Clinical Results associated with Qingdao Guofeng Group Huayang Parmaceutical Co. Ltd.
0 Patents (Medical) associated with Qingdao Guofeng Group Huayang Parmaceutical Co. Ltd.
100 Deals associated with Qingdao Guofeng Group Huayang Parmaceutical Co. Ltd.
100 Translational Medicine associated with Qingdao Guofeng Group Huayang Parmaceutical Co. Ltd.