/ CompletedNot Applicable 利丙双卡因乳膏在健康受试者空腹状态下的随机、开放、两序列、两周期、双交叉人体生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of leprocaine cream in healthy subjects under fasting condition
主要目的：
研究空腹单次涂抹利丙双卡因乳膏受试制剂15g（规格：1g：利多卡因25mg，丙胺卡因25mg；由景时（杭州）药业有限公司提供）与利丙双卡因乳膏参比制剂15g（规格：1g：利多卡因25mg，丙胺卡因25mg；持证商：Aspen Pharma Trading Limited，由景时（杭州）药业有限公司提供）在中国健康受试者体内的药代动力学行为，评价空腹涂抹两种制剂的生物等效性。
次要目的：
评价中国健康受试者单次涂抹利丙双卡因乳膏受试制剂和利丙双卡因乳膏参比制剂后的安全性。
[Translation] Primary objective:
To study the pharmacokinetic behavior of a single application of the test formulation of 15g of levocaine cream (Specification: 1g: 25mg lidocaine, 25mg prilocaine; provided by Jingshi (Hangzhou) Pharmaceutical Co., Ltd.) and the reference formulation of 15g of levocaine cream (Specification: 1g: 25mg lidocaine, 25mg prilocaine; licensee: Aspen Pharma Trading Limited, provided by Jingshi (Hangzhou) Pharmaceutical Co., Ltd.) in healthy Chinese subjects, and to evaluate the bioequivalence of the two formulations applied on an empty stomach.
Secondary objective:
To evaluate the safety of a single application of the test formulation of levocaine cream and the reference formulation of levocaine cream in healthy Chinese subjects.
/ CompletedNot Applicable 盐酸达泊西汀片随机、开放、单剂量、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A formal bioequivalence study of dapoxetine hydrochloride tablets in Chinese healthy subjects using a randomized, open-label, single-dose, two-dose, crossover design
主要目的：以景时（杭州）药业有限公司的盐酸达泊西汀片为受试制剂；并以Berlin-Chemie AG持证的盐酸达泊西汀片为参比制剂，进行人体相对生物利用度和生物等效性评价。
[Translation] Main purpose: To evaluate the relative bioavailability and bioequivalence of dapoxetine hydrochloride tablets produced by Jingshi (Hangzhou) Pharmaceutical Co., Ltd. as the test preparation and dapoxetine hydrochloride tablets certified by Berlin-Chemie AG as the reference preparation.
/ CompletedNot Applicable 一项在健康男性受试者中于空腹情况下进行的关于枸橼酸西地那非口崩片的单剂量、随机、开放性、两制剂、两周期、交叉的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-formulation, two-period, crossover bioequivalence study of sildenafil citrate orodisintegrating tablets in healthy male subjects under fasting conditions
主要研究目的
研究空腹状态下单次口服受试制剂枸橼酸西地那非口崩片（规格：50 mg，由浙江京新药业股份有限公司生产，景时(杭州)药业有限公司提供）与枸橼酸西地那非口崩片（万艾可®，规格：50 mg；Pfizer Limited持证，景时(杭州)药业有限公司提供）在健康成年受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。
次要研究目的
研究受试制剂枸橼酸西地那非口崩片和参比制剂枸橼酸西地那非口崩片（万艾可®）在健康成年受试者中的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation sildenafil citrate orodisintegrating tablets (specification: 50 mg, produced by Zhejiang Jingxin Pharmaceutical Co., Ltd., provided by Jingshi (Hangzhou) Pharmaceutical Co., Ltd.) and sildenafil citrate orodisintegrating tablets (Viagra®, specification: 50 mg; licensed by Pfizer Limited, provided by Jingshi (Hangzhou) Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions.
Secondary study objectives
To study the safety of the test preparation sildenafil citrate orodisintegrating tablets and the reference preparation sildenafil citrate orodisintegrating tablets (Viagra®) in healthy adult subjects.
100 Clinical Results associated with Jingshi (Hangzhou) Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jingshi (Hangzhou) Pharmaceutical Co., Ltd.
100 Deals associated with Jingshi (Hangzhou) Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jingshi (Hangzhou) Pharmaceutical Co., Ltd.
