|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date30 Sep 2015 |
|
Mechanism5-HT2A receptor antagonists [+1] |
|
|
|
|
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
|
MechanismBacterial DNA gyrase inhibitors [+1] |
Active Org.- |
|
Active Indication- |
|
Drug Highest PhaseDiscontinued |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Study on human bioequivalence of valacyclovir hydrochloride tablets
主要目的:采用单中心、随机、开放、双周期、自身交叉、单剂量空腹/餐后给药设计,比较德全药品(江苏)股份有限公司生产的盐酸伐昔洛韦片(商品名:VALTREX®/维德思®,规格:0.5 g)与The Wellcome Foundation Limited持证Glaxo Wellcome SA生产的盐酸伐昔洛韦片(规格:0.5 g)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:评价盐酸伐昔洛韦片(规格:0.5 g)受试制剂和参比制剂在健康受试者体内的安全性。
[Translation] Main purpose: Using a single-center, randomized, open, double-cycle, self-crossover, single-dose fasting/postprandial dosing design, compare Valacyclovir Hydrochloride Tablets (trade name: VALTREX) produced by Dequan Pharmaceutical (Jiangsu) Co., Ltd. Evaluation of the difference in absorption degree and speed among healthy Chinese people between valaciclovir hydrochloride tablets (specification: 0.5 g) produced by The Wellcome Foundation Limited and Glaxo Wellcome SA licensed by The Wellcome Foundation Limited (Specification: 0.5 g) Bioequivalence. Secondary purpose: To evaluate the safety of valacyclovir hydrochloride tablets (specification: 0.5 g) test preparation and reference preparation in healthy subjects.
[Translation] Bioequivalence Study of Valacyclovir Hydrochloride Tablets in Human
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计,分别评价空腹和餐后给药条件下德全药品(江苏)股份有限公司生产的盐酸伐昔洛韦片(规格:0.5 g)与The Wellcome Foundation Limited持证Glaxo Wellcome SA生产的的盐酸伐昔洛韦片(商品名:VALTREX®/维德思®,规格:0.5 g)在中国健康人群中吸收程度和吸收速度的差异,并评价德全药品(江苏)股份有限公司持证的盐酸伐昔洛韦片(规格:0.5 g)的安全性。
[Translation] Adopt single-center, random, open, two-period, self-crossover, single-dose administration design, evaluate the valacyclovir hydrochloride tablet (specification: 0.5 g) and the absorption degree and absorption speed of valacyclovir hydrochloride tablets (trade name: VALTREX®/维德斯®, specification: 0.5 g) produced by The Wellcome Foundation Limited licensed Glaxo Wellcome SA in Chinese healthy people and evaluate the safety of valacyclovir hydrochloride tablets (specification: 0.5 g) licensed by Dequan Pharmaceutical (Jiangsu) Co., Ltd.
[Translation] Bioequivalence Study of Liprobicaine Cream in Humans
采用单中心、随机、开放、双周期交叉、空腹试验设计比较健康受试者单次使用永信药品工业(昆山)股份有限公司提供的利丙双卡因乳膏(规格:30g(1g:利多卡因25mg,丙胺卡因25mg))与Aspen Pharma Trading Limited持证的原研进口利丙双卡因乳膏(商品名:EMLA®,规格:30g(1g:利多卡因25mg,丙胺卡因25mg))在中国健康人群中吸收程度和吸收速度的差异,并评价两制剂的安全性。
[Translation] A single-center, randomized, open, two-period crossover, fasting trial design was used to compare the single use of Liprobicaine Cream (specification: 30g (1g: Lido) provided by Yongxin Pharmaceutical Industry (Kunshan) Co., Ltd. in healthy subjects 25mg of caine, 25mg of prilocaine)) and imported ripricaine cream licensed by Aspen Pharma Trading Limited (trade name: EMLA®, specification: 30g (1g: 25mg of lidocaine, 25mg of prilocaine) ) differences in the degree of absorption and rate of absorption in healthy Chinese populations, and to evaluate the safety of the two preparations.
100 Clinical Results associated with Yung Shin Pharm Ind Kunshan Co. Ltd.
0 Patents (Medical) associated with Yung Shin Pharm Ind Kunshan Co. Ltd.
100 Deals associated with Yung Shin Pharm Ind Kunshan Co. Ltd.
100 Translational Medicine associated with Yung Shin Pharm Ind Kunshan Co. Ltd.