/ CompletedNot Applicable [Translation] Bioequivalence study of flurbiprofen gel patch in human body
主要目的:
采用单中心、随机、开放、两制剂、双周期交叉、空腹试验设计,比较空腹给药条件下,杭州泓友医药科技有限公司提供的氟比洛芬凝胶贴膏(40 mg/贴)与Mikasa Seiyaku Co.,Ltd持证的氟比洛芬凝胶贴膏(商品名:泽普思®,规格:40 mg/贴)在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
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在中国健康受试者用药过程中的黏附性;3)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] Main purpose:
A single-center, randomized, open, two-drug, two-period crossover, fasting trial design was used to compare the differences in absorption degree and absorption rate of flurbiprofen gel patch (40 mg/patch) provided by Hangzhou Hongyou Pharmaceutical Technology Co., Ltd. and flurbiprofen gel patch (trade name: Zepus®, specification: 40 mg/patch) certified by Mikasa Seiyaku Co., Ltd. in healthy Chinese people under fasting administration conditions, and evaluate bioequivalence.
Secondary objectives:
1) Evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects; 2) Evaluate the adhesion of the test preparation and the reference preparation during medication in healthy Chinese subjects; 3) Evaluate the skin reactivity of the test preparation and the reference preparation in healthy Chinese subjects.
/ CompletedNot Applicable [Translation] Bioequivalence study of fluvastatin sodium sustained-release tablets in healthy volunteers
氟伐他汀钠缓释片在健康受试者中空腹和餐后状态下的单剂量、随机、开放、四周期、两序列、重复交叉设计的生物等效性试验。研究空腹和餐后状态下单次口服受试制剂氟伐他汀钠缓释片(规格:80mg/片,杭州泓友医药科技有限公司)与参比制剂氟伐他汀钠缓释片(商品名:来适可®,规格:80mg/片,北京诺华制药有限公司)在健康成年受试者体内的药代动力学,评价两制剂生物等效性。
[Translation] A single-dose, randomized, open-label, four-period, two-sequence, repeated crossover bioequivalence study of fluvastatin sodium extended-release tablets in healthy subjects under fasting and fed conditions. The pharmacokinetics of the test preparation fluvastatin sodium extended-release tablets (specification: 80 mg/tablet, Hangzhou Hongyou Pharmaceutical Technology Co., Ltd.) and the reference preparation fluvastatin sodium extended-release tablets (trade name: Lescol®, specification: 80 mg/tablet, Beijing Novartis Pharmaceutical Co., Ltd.) were studied in healthy adult subjects under fasting and fed conditions to evaluate the bioequivalence of the two preparations.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of dopamine tablets in healthy volunteers
采用单中心、随机、开放、三周期、部分重复交叉、单次口服试验设计比较空腹和餐后给
药条件下,杭州泓友医药科技有限公司提供的多巴丝肼片(左旋多巴 200 mg 与苄丝肼 50 mg
(相当于盐酸苄丝肼 57 mg))与上海罗氏制药有限公司持证的多巴丝肼片(左旋多巴 200 mg
与苄丝肼 50 mg(相当于盐酸苄丝肼 57 mg),商品名:美多芭®)在中国健康人群吸收程度和
吸收速度的差异,并评价杭州泓友医药科技有限公司提供的多巴丝肼片的安全性。
[Translation] A single-center, randomized, open, three-period, partially repeated crossover, single oral trial design was used to compare the differences in absorption degree and absorption rate of dopamine tablets (200 mg levodopa and 50 mg benserazide (equivalent to 57 mg benserazide hydrochloride) provided by Hangzhou Hongyou Pharmaceutical Technology Co., Ltd. and dopamine tablets (200 mg levodopa and 50 mg benserazide (equivalent to 57 mg benserazide hydrochloride) licensed by Shanghai Roche Pharmaceuticals Co., Ltd., trade name: Madopar®) in healthy Chinese population under fasting and postprandial dosing conditions, and to evaluate the safety of dopamine tablets provided by Hangzhou Hongyou Pharmaceutical Technology Co., Ltd.
100 Clinical Results associated with Hangzhou Hongyou Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Hangzhou Hongyou Pharmaceutical Technology Co., Ltd.
100 Deals associated with Hangzhou Hongyou Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Hangzhou Hongyou Pharmaceutical Technology Co., Ltd.