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�й�������־ 2009, 34(11) 699- DOI:   1001-8689��2009��11-0699-04  ISSN: 0412-1961 CN: 21-1139/TG

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Article by Wang, X. G.
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Phase I clinical toleratnce study of cefuroxime/sulbactam
1 Department of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu 610041 ; 2 Shenzhen saluberis pharmaceuticals CO. , LTD, Shenzhen 518040
Abstract:

Objective To evaluate the safety and tolerance of cefuroxime/sulbactam intravenous infusion in Chinese healthy volunteers. Methods The trial protocol was designed according to the Good Clinical Practice��GCP��. 66 healthy volunteers were received a single dose intravenous infusion of 0.75g, 1.5g, 3.0g, 4.5g, 6.0g, 7.5 g and 9.0g or multiple doses intravenous infusion of 7.5g, 9.0g cefuroxime/sulbactam respectively. Clinical symptoms, laboratory parameters and electrocardiogram were monitored during the trial. Results Sixty-six healthy volunteers were well tolerated with the cefuroxime/sulbactam. During the study of multiple doses intravenous infusion of 9. 0g cefuroxime/sulbactam, only 3 cases of adverse events were found, such as vein irritation, mild diarrhea, transient leukopenia, but the adverse events were relief quickly. Conclusion Cefuroxime/sulbactam was safe and well tolerated after single dose and multiple doses administrated in Chinese subjects.

Keywords: Cefuroxime    Sulbactam    Safety    Tolerance  
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DOI: 1001-8689��2009��11-0699-04
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