[Translation] Phase III clinical trial of the efficacy and safety of ceftriaxone sodium and tazobactam sodium for injection (6:1) in the treatment of moderate to severe acute bacterial infections of the lower respiratory tract and urinary system

以注射用头孢曲松钠他唑巴坦钠（3:1）为对照，进一步评价注射用头孢曲松钠他唑巴坦钠（6:1）治疗中、重度下呼吸道和泌尿系统急性细菌感染的有效性和安全性。

[Translation]

Using ceftriaxone sodium and tazobactam sodium for injection (3:1) as a control, the efficacy and safety of ceftriaxone sodium and tazobactam sodium for injection (6:1) in the treatment of moderate to severe acute bacterial infections of the lower respiratory tract and urinary system were further evaluated.

Start Date-

Sponsor / Collaborator

Xiangbei Welman Pharmaceutical Co., Ltd.

CTR20132852 / Active, not recruitingPhase 2

注射用头孢曲松钠他唑巴坦钠（6:1）治疗中、重度下呼吸道和泌尿系统急性细菌感染Ⅱ期临床试验

[Translation] Phase II clinical trial of ceftriaxone sodium and tazobactam sodium for injection (6:1) in the treatment of moderate to severe acute bacterial infections of the lower respiratory tract and urinary system

以注射用头孢曲松钠他唑巴坦钠（3:1）为对照，评价注射用头孢曲松钠他唑巴坦钠（6:1）治疗中、重度下呼吸道和泌尿系统急性细菌感染的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of ceftriaxone sodium and tazobactam sodium for injection (6:1) in the treatment of moderate to severe acute bacterial infections of the lower respiratory tract and urinary system, using ceftriaxone sodium and tazobactam sodium for injection (3:1) as a control.

Start Date17 May 2011

Sponsor / Collaborator

Xiangbei Welman Pharmaceutical Co., Ltd.

CTR20132376 / CompletedPhase 1

单中心、开放、随机分组注射用头孢曲松钠他唑巴坦钠单、多次给药药代动力学及相互作用临床研究

[Translation] A single-center, open-label, randomized clinical study on the pharmacokinetics and interactions of single and multiple doses of ceftriaxone sodium and tazobactam sodium for injection

健康受试者进行注射用头孢曲松钠他唑巴坦钠的药代动力学试验，测定主要成分头孢曲松钠和他唑巴坦钠的经时血药浓度，计算主要药代动力学参数，了解注射用头孢曲松钠他唑巴坦钠在人体吸收、分布、消除、代谢规律，为制定注射用头孢曲松钠他唑巴坦钠II期临床试验方案提供试验依据。

[Translation]

A pharmacokinetic study of ceftriaxone sodium and tazobactam sodium for injection was conducted on healthy subjects to determine the time-dependent blood concentrations of the main components, ceftriaxone sodium and tazobactam sodium, and calculate the main pharmacokinetic parameters to understand the absorption, distribution, elimination, and metabolism of ceftriaxone sodium and tazobactam sodium for injection in the human body, so as to provide an experimental basis for the formulation of the Phase II clinical trial plan for ceftriaxone sodium and tazobactam sodium for injection.

Start Date22 Jul 2010

Sponsor / Collaborator

China Pharma Holdings, Inc.

100 Clinical Results associated with Ceftriaxone Sodium/Tazobactam Sodium

100 Translational Medicine associated with Ceftriaxone Sodium/Tazobactam Sodium

100 Patents (Medical) associated with Ceftriaxone Sodium/Tazobactam Sodium

100 Deals associated with Ceftriaxone Sodium/Tazobactam Sodium

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bacterial Infections	CN	Haikou Qili Pharmaceutical Co., Ltd.	09 Apr 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Bronchitis	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Acute pyelonephritis	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Bronchiectasis	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Community Acquired Pneumonia	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Complicated urinary tract infection	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Hospital-acquired pneumonia	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Lower Respiratory Tract Infections	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Pulmonary Disease, Chronic Obstructive	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	17 May 2011
Urinary Tract Infections	Phase 1	CN	China Pharma Holdings, Inc.	22 Jul 2010

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