1. To study the pharmacokinetic characteristics and safety of single intravenous infusion of low, medium and high doses of cefotaxime sodium and tazobactam sodium for injection (6:1) in humans; 2. To study the drug interactions of cefotaxime sodium and tazobactam sodium for injection (6:1) in humans; 3. To study the pharmacokinetic characteristics and safety of multiple intravenous infusions of cefotaxime sodium and tazobactam sodium for injection (6:1) in humans.

Start Date23 Jul 2019

Sponsor / Collaborator

Xiangbei Welman Pharmaceutical Co., Ltd.

CTR20190751 / CompletedPhase 1

注射用头孢噻肟钠他唑巴坦钠（6:1）健康人体耐受性、药动学及药物相互作用研究

[Translation] Study on the tolerability, pharmacokinetics and drug interactions of cefotaxime sodium and tazobactam sodium for injection (6:1) in healthy volunteers

通过健康受试者单次和多次静脉输注试验药物，评价用于人体的安全性和耐受性；研究该药物在健康受试者体内的药动学特征；通过测定健康受试者分别静脉输注试验药物、注射用头孢噻肟钠以及注射用他唑巴坦钠后血浆中药物浓度变化，考察头孢噻肟和他唑巴坦之间是否有药代动力学相互作用。

[Translation]

The safety and tolerability of the test drug for use in humans were evaluated by single and multiple intravenous infusions of the test drug in healthy subjects. The pharmacokinetic characteristics of the drug in healthy subjects were studied. The pharmacokinetic interaction between cefotaxime and tazobactam was investigated by measuring the changes in plasma drug concentrations after intravenous infusion of the test drug, cefotaxime sodium for injection, and tazobactam sodium for injection in healthy subjects.

Start Date13 Apr 2017

Sponsor / Collaborator

Guangdong South China New Drug Creation Center

[+3]

CTR20131005 / CompletedPhase 3

注射用头孢噻肟钠他唑巴坦钠治疗呼吸和泌尿系统急性细菌性感染的疗效和安全性的Ⅲ期临床试验

[Translation] Phase III clinical trial on the efficacy and safety of cefotaxime sodium and tazobactam sodium for injection in the treatment of acute bacterial infections of the respiratory and urinary systems

确证湘北威尔曼制药股份有限公司研制开发的注射用头孢噻肟钠他唑巴坦钠治疗呼吸系统和泌尿系统急性细菌性感染的有效性和安全性。

[Translation]

To confirm the effectiveness and safety of cefotaxime sodium and tazobactam sodium for injection developed by Xiangbei Wellman Pharmaceutical Co., Ltd. in the treatment of acute bacterial infections of the respiratory and urinary systems.

Start Date09 Sep 2013

Sponsor / Collaborator

Xiangbei Welman Pharmaceutical Co., Ltd.

100 Clinical Results associated with Cefotaxime Sodium/Tazobactam Sodium

100 Translational Medicine associated with Cefotaxime Sodium/Tazobactam Sodium

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

100 Deals associated with Cefotaxime Sodium/Tazobactam Sodium

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Infectious Diseases	CN	Nanjing YOKO Pharmaceutical Co., Ltd.	22 Oct 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacterial lower respiratory infection	Phase 2	CN	Nanjing Fusheng Pharmaceutical Technology Co., Ltd.	23 Aug 2012
Bacterial lower respiratory infection	Phase 2	CN	Nanjing Chang'ao Pharmaceutical Co., Ltd.	23 Aug 2012
Genitourinary tract infection	Phase 2	CN	Nanjing Chang'ao Pharmaceutical Co., Ltd.	23 Aug 2012
Genitourinary tract infection	Phase 2	CN	Nanjing Fusheng Pharmaceutical Technology Co., Ltd.	23 Aug 2012
Respiratory Diseases	Phase 1	CN	Nanjing Yoko Pharmaceutical Group Co. Ltd.	13 Apr 2017
Respiratory Diseases	Phase 1	CN	Guangdong South China New Drug Creation Center	13 Apr 2017

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