Delving into the Latest Updates on Changzhou Ruiming Pharmaceutical Co Ltd. with Synapse

Overview

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂盐酸坦索罗辛缓释胶囊（规格：0.2 mg，生产厂家：常州瑞明药业股份有限公司）与参比制剂盐酸坦索罗辛缓释胶囊（规格：0.2 mg，持证商：安斯泰来制药（中国）有限公司，商品名：哈乐®）后在中国健康受试者体内的药代动力学行为，评价受试制剂与参比制剂的生物等效性。次要目的：观察受试制剂盐酸坦索罗辛缓释胶囊和参比制剂盐酸坦索罗辛缓释胶囊在中国健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation Tamsulosin Hydrochloride Sustained-Release Capsules (Specification: 0.2 mg, manufacturer: Changzhou Ruiming Pharmaceutical Co., Ltd.) and the reference preparation Tamsulosin Hydrochloride Sustained-Release Capsules (Specification: 0.2 mg, licensee: Astellas Pharmaceuticals (China) Co., Ltd., trade name: Harle®) in healthy Chinese subjects after oral administration in fasting/postprandial state was compared to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary purpose: To observe the safety of the test preparation Tamsulosin Hydrochloride Sustained-Release Capsules and the reference preparation Tamsulosin Hydrochloride Sustained-Release Capsules in healthy Chinese subjects.

Start Date-

Sponsor / Collaborator

Changzhou Ruiming Pharmaceutical Co Ltd.

CTR20243035

/ TerminatedNot Applicable

盐酸坦索罗辛缓释胶囊在健康受试者中的随机、开放、单剂量、两周期、双交叉空腹及餐后生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of tamsulosin hydrochloride extended-release capsules in healthy subjects

主要目的：以常州瑞明药业有限公司研制的盐酸坦索罗辛缓释胶囊（规格：0.2 mg）为受试制剂，按生物等效性试验的有关规定，与安斯泰来制药（中国）有限公司生产的盐酸坦索罗辛缓释胶囊（商品名：哈乐®，规格：0.2 mg）为参比制剂，对比在健康人体内的相对生物利用度，研究两制剂的人体生物等效性。次要目的：观察盐酸坦索罗辛缓释胶囊受试制剂和参比制剂（商品名：哈乐®）在健康受试者中的安全性。

[Translation]

Main purpose: Using tamsulosin hydrochloride sustained-release capsules (specification: 0.2 mg) developed by Changzhou Ruiming Pharmaceutical Co., Ltd. as the test preparation, and tamsulosin hydrochloride sustained-release capsules (trade name: Harle®, specification: 0.2 mg) produced by Astellas Pharma (China) Co., Ltd. as the reference preparation, the relative bioavailability in healthy humans was compared to study the human bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation and reference preparation (trade name: Harle®) of tamsulosin hydrochloride sustained-release capsules in healthy subjects.

Start Date04 Sep 2024

Sponsor / Collaborator

Changzhou Ruiming Pharmaceutical Co Ltd.

CTR20221886

/ CompletedNot Applicable

苯磺酸左氨氯地平片在健康受试者中的随机、开放、单剂量、双周期、自身交叉空腹及餐后生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, self-crossover bioequivalence study of levamlodipine besylate tablets in healthy subjects under fasting and fed conditions

主要研究目的：以常州瑞明药业有限公司研发的苯磺酸左氨氯地平片（规格：5 mg）为受试制剂，按生物等效性研究的有关规定，与辉瑞制药有限公司生产的苯磺酸氨氯地平片（规格：10 mg，参比制剂，商品名：络活喜®）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：比较受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片（商品名：络活喜®）在健康受试者中的安全性。

[Translation]

Main research purpose: Using levamlodipine besylate tablets (specification: 5 mg) developed by Changzhou Ruiming Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the relative bioavailability of amlodipine besylate tablets (specification: 10 mg, reference preparation, trade name: Norvasc®) produced by Pfizer Pharmaceuticals Co., Ltd. was compared in healthy humans, and the human bioequivalence of the two preparations was investigated. Secondary research purpose: To compare the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (trade name: Norvasc®) in healthy subjects.

Start Date01 Sep 2022

Sponsor / Collaborator

Changzhou Ruiming Pharmaceutical Co Ltd.

100 Clinical Results associated with Changzhou Ruiming Pharmaceutical Co Ltd.

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0 Patents (Medical) associated with Changzhou Ruiming Pharmaceutical Co Ltd.

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Literatures (Medical) associated with Changzhou Ruiming Pharmaceutical Co Ltd.

Organic & Biomolecular Chemistry

Diboron-promoted iron-catalyzed denitrative vinylation of β-nitrostyrenes with cycloketoximes

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