[Translation] A randomized, open-label, three-period crossover, multiple-dose comparison of the pharmacokinetics of amoxicillin-ambroxol tablets, amoxicillin tablets, and ambroxol hydrochloride tablets (two drugs used alone)

本试验旨在研究北京国联诚辉医药技术有限公司研制、生产的阿莫西林氨溴索片（每片含阿莫西林250mg和盐酸氨溴索15mg）与单用一种制剂（阿莫西林片或盐酸氨溴索片）的健康人体比较药动学，以提供阿莫西林与氨溴索在健康人体内相互影响与否的药动学数据，为该药的组方设计是否合理提供临床试验依据，为该药进行Ⅱ期临床研究提供依据。

[Translation]

The purpose of this study is to study the pharmacokinetics of amoxicillin and ambroxol tablets (each tablet contains 250 mg amoxicillin and 15 mg ambroxol hydrochloride) developed and produced by Beijing Guolian Chenghui Pharmaceutical Technology Co., Ltd. and a single preparation (amoxicillin tablets or ambroxol hydrochloride tablets) in healthy humans, so as to provide pharmacokinetic data on whether amoxicillin and ambroxol affect each other in healthy humans, provide clinical trial basis for whether the formulation design of the drug is reasonable, and provide basis for conducting phase II clinical research on the drug.

Start Date-

Sponsor / Collaborator

Beijing Guolian Chenghui Medicine Technology Co., Ltd.

CTR20132147

/ Not yet recruitingPhase 1

阿莫西林氨溴索胶囊人体药代动力学Ⅰ期临床试验

[Translation] Phase I Clinical Trial on the Pharmacokinetics of Amoxicillin and Ambroxol Capsules in Humans

研究本公司研制的阿莫西林氨溴索胶囊在健康成人体内的药代动力学特性。

[Translation]

To study the pharmacokinetic properties of amoxicillin-ambroxol capsules developed by our company in healthy adults.

Start Date-

Sponsor / Collaborator

Beijing Hua Xi Lianhe Tech & Development Ltd.

CTR20132262

/ Not yet recruitingNot Applicable

阿莫西林氨溴索胶囊人体药代动力学

[Translation] Pharmacokinetics of Amoxicillin and Ambroxol Capsules in Healthy Volunteers

研究本公司研制的阿莫西林氨溴索胶囊在中国健康成人体内的药代动力学特性，为临床安全、合理用药提供参考依据。

[Translation]

The pharmacokinetic characteristics of amoxicillin and ambroxol capsules developed by our company in healthy Chinese adults were studied to provide a reference for safe and rational clinical use of drugs.

Start Date-

Sponsor / Collaborator

Beijing Hua Xi Lianhe Tech & Development Ltd.

100 Clinical Results associated with Ambroxol Hydrochloride/Amoxicillin

100 Translational Medicine associated with Ambroxol Hydrochloride/Amoxicillin

100 Patents (Medical) associated with Ambroxol Hydrochloride/Amoxicillin

100 Deals associated with Ambroxol Hydrochloride/Amoxicillin

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Bronchitis	Phase 1	CN	-	07 May 2014
Acute respiratory infections	Phase 1	CN	-	07 May 2014
Asthma	Phase 1	CN	-	07 May 2014
Asthmatic bronchitis	Phase 1	CN	-	07 May 2014
Bronchiectasis	Phase 1	CN	-	07 May 2014
Bronchitis, Chronic	Phase 1	CN	-	07 May 2014
Otitis Media	Phase 1	CN	-	07 May 2014
Pharyngitis	Phase 1	CN	-	07 May 2014
respiratory tract; infection, chronic	Phase 1	CN	-	07 May 2014

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