[Translation] An open-label, single-arm, phase IV study to evaluate the efficacy and safety of roxithromycin and ambroxol tablets in patients with lower respiratory tract bacterial infection and symptoms of thick sputum

通过治疗前后的比较，评价罗红霉素氨溴索片对于下呼吸道细菌性感染患者在祛痰和抗菌方面的疗效；通过治疗前后的比较，评价罗红霉素氨溴索片对于下呼吸道细菌性感染患者在症状体征消失方面的疗效；通过治疗前后的比较，评价罗红霉素氨溴索片对于下呼吸道细菌性感染患者的安全性

[Translation]

To evaluate the efficacy of Roxithromycin Ambroxol Tablets in expectoration and antibacterial treatment of patients with lower respiratory tract bacterial infection by comparing before and after treatment; To evaluate the efficacy of Roxithromycin Ambroxol Tablets in eliminating symptoms and signs of patients with lower respiratory tract bacterial infection by comparing before and after treatment; To evaluate the safety of Roxithromycin Ambroxol Tablets in patients with lower respiratory tract bacterial infection by comparing before and after treatment

Start Date30 Oct 2017

Sponsor / Collaborator

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

CTR20140560

/ Recruiting

复方罗红霉素片治疗轻中度急性下呼吸道细菌感染伴有痰液粘稠的随机双盲双模拟阳性药平行对照多中心临床试验

[Translation] A randomized, double-blind, double-dummy, positive-drug parallel controlled multicenter clinical trial of compound roxithromycin tablets in the treatment of mild to moderate acute lower respiratory tract bacterial infections with viscous sputum

以罗红霉素为对照，进一步评价复方罗红霉素片治疗轻、中度急性下呼吸道细菌感染伴有痰液粘稠的安全性和有效性

[Translation]

To further evaluate the safety and efficacy of compound roxithromycin tablets in the treatment of mild and moderate acute lower respiratory tract bacterial infections with viscous sputum using roxithromycin as a control

Start Date03 Jul 2014

Sponsor / Collaborator

Hefei Chuandi Pharmaceutical Technology Co., Ltd.

CTR20131241

/ CompletedPhase 1

罗红霉素盐酸氨溴索分散片人体药代动力学试验

[Translation] Pharmacokinetics of Roxithromycin Hydrochloride and Ambroxol Dispersible Tablets in Human Body

以罗红霉素盐酸氨溴索分散片为受试制剂，考察受试者服药后的体内药动学特点，为临床合理化用药提供依据。

[Translation]

Roxithromycin hydrochloride and ambroxol dispersible tablets were used as the test preparation to investigate the pharmacokinetic characteristics of the subjects after taking the drug, so as to provide a basis for rational clinical drug use.

Start Date05 Aug 2011

Sponsor / Collaborator

Furen Medicines Group Co., Ltd.

100 Clinical Results associated with Roxithromycin/Ambroxol Hydrochloride

100 Translational Medicine associated with Roxithromycin/Ambroxol Hydrochloride

100 Patents (Medical) associated with Roxithromycin/Ambroxol Hydrochloride

100 Deals associated with Roxithromycin/Ambroxol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J01FA06 R05CB06	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bronchitis	China	Jiangsu Yabang Epson Pharmaceutical Co Ltd.	15 Jan 2010
Bronchitis, Chronic	China	Jiangsu Yabang Epson Pharmaceutical Co Ltd.	15 Jan 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Tract Infections	Phase 2	China	Furen Medicines Group Co., Ltd.	-
Acute Bronchitis	Phase 1	China	Hefei Chuandi Pharmaceutical Technology Co., Ltd.	09 Oct 2008
Asthma	Phase 1	China	Hefei Chuandi Pharmaceutical Technology Co., Ltd.	09 Oct 2008
Bacterial Infections	Phase 1	China	Hefei Chuandi Pharmaceutical Technology Co., Ltd.	09 Oct 2008
Bronchiectasis	Phase 1	China	Hefei Chuandi Pharmaceutical Technology Co., Ltd.	09 Oct 2008
Lower Respiratory Tract Infections	Phase 1	China	Hefei Chuandi Pharmaceutical Technology Co., Ltd.	09 Oct 2008
Pneumonia	Phase 1	China	Hefei Chuandi Pharmaceutical Technology Co., Ltd.	09 Oct 2008
Tracheitis	Phase 1	China	Hefei Chuandi Pharmaceutical Technology Co., Ltd.	09 Oct 2008

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