[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of dapoxetine hydrochloride tablets in healthy Chinese adult male subjects under fasting and fed conditions

主要研究目的：考察单次口服60mg（空腹/餐后）受试制剂盐酸达泊西汀片和参比制剂盐酸达泊西汀片，在中国成年健康男性受试者体内的药代动力学特征，验证空腹与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：评价单次口服60mg（空腹/餐后）受试制剂和参比制剂在中国成年健康男性受试者中的安全性。

[Translation]

Main study objectives: To investigate the pharmacokinetic characteristics of the test preparation dapoxetine hydrochloride tablets and the reference preparation dapoxetine hydrochloride tablets in healthy adult male subjects in China after a single oral administration of 60 mg (fasting/after meals), and to verify the bioequivalence of the two preparations under fasting and after meals conditions. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy adult male subjects in China after a single oral administration of 60 mg (fasting/after meals).

Start Date20 Sep 2024

Sponsor / Collaborator

Guoda (Jilin) Pharmaceutical Group Co., Ltd

CTR20242777 / CompletedNot Applicable

利丙双卡因乳膏在中国成年健康受试者中的一项单中心、随机、开放、空腹单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, fasting, two-formulation, two-sequence, two-period crossover bioequivalence study of leprocaine cream in healthy adult Chinese subjects

考察空腹单次使用受试制剂利丙双卡因乳膏15g（规格：1g：利多卡因25mg，丙胺卡因25mg，南昌立健药业有限公司生产，国大（吉林）制药集团有限公司提供）与参比制剂利丙双卡因乳膏15g（Emla®，规格：1g：利多卡因25mg，丙胺卡因25mg，AstraZeneca AB 持证），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价空腹单次使用受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

To investigate the relative bioavailability of the test preparation 15g of levocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg, produced by Nanchang Lijian Pharmaceutical Co., Ltd., provided by Guoda (Jilin) Pharmaceutical Group Co., Ltd.) and the reference preparation 15g of levocaine cream (Emla®, specification: 1g: lidocaine 25mg, prilocaine 25mg, licensed by AstraZeneca AB) in healthy Chinese subjects after single fasting administration, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference basis for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects after single fasting administration.

Start Date08 Aug 2024

Sponsor / Collaborator

Guoda (Jilin) Pharmaceutical Group Co., Ltd

CTR20241868 / CompletedNot Applicable

布洛芬缓释胶囊 0.3g随机、开放、两周期、两交叉健康受试者空腹及餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of ibuprofen sustained-release capsules 0.3 g in healthy subjects in the fasting and fed state

主要目的：研究空腹及餐后状态下单次口服受试制剂布洛芬缓释胶囊（规格：0.3g，天津力生制药股份有限公司生产）与参比制剂布洛芬缓释胶囊（芬必得®，规格：0.3g；中美天津史克制药有限公司生产）在健康受试者体内的生物等效性。次要目的：研究受试制剂布洛芬缓释胶囊0.3g和参比制剂（商品名：芬必得®）0.3g在健康受试者中的安全性。

[Translation]

Primary objective: To study the bioequivalence of a single oral dose of the test preparation ibuprofen sustained-release capsule (specification: 0.3g, produced by Tianjin Lisheng Pharmaceutical Co., Ltd.) and the reference preparation ibuprofen sustained-release capsule (Fenbid®, specification: 0.3g; produced by Sino-US Tianjin SmithKline Pharmaceutical Co., Ltd.) in healthy subjects. Secondary objective: To study the safety of the test preparation ibuprofen sustained-release capsule 0.3g and the reference preparation (trade name: Fenbid®) 0.3g in healthy subjects.

Start Date07 Jun 2024

Sponsor / Collaborator

Guoda (Jilin) Pharmaceutical Group Co., Ltd

100 Clinical Results associated with Guoda (Jilin) Pharmaceutical Group Co., Ltd

0 Patents (Medical) associated with Guoda (Jilin) Pharmaceutical Group Co., Ltd

100 Deals associated with Guoda (Jilin) Pharmaceutical Group Co., Ltd

100 Translational Medicine associated with Guoda (Jilin) Pharmaceutical Group Co., Ltd

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Guoda (Jilin) Pharmaceutical Group Co., Ltd

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