Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-Controlled Studies

Merdjan Henri; Rangaraju Manickam; Tarral Antoine

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Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-Controlled Studies

机译：单独和多次递增剂量的阿维巴坦单独使用和与头孢他啶联用在健康男性志愿者中的安全性和药代动力学：两项随机，安慰剂对照研究的结果

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Background and Objective Avibactam is a novel non-beta-lactam beta-lactamase inhibitor effective against Ambler class A, C and some class D beta-lactamases that is currently in clinical development in combination with ceftazidime for the treatment of serious Gram-negative infections. It restores the in vitro activity of a range of beta-lactams, including ceftazidime, against extended-spectrum beta-lactamase-producing pathogens. Two phase I studies assessed the safety and pharmacokinetics of avibactam in healthy subjects when administered alone or with ceftazidime.

机译：背景与目的阿维巴坦（Avibactam）是一种新型的非β-内酰胺β-内酰胺酶抑制剂，对Ambler A，C类和某些D类β-内酰胺酶有效，目前正在与头孢他啶联合用于临床治疗严重的革兰氏阴性感染。它可恢复包括头孢他啶在内的一系列β-内酰胺类药物对产生广谱β-内酰胺酶的病原体的体外活性。两项I期研究评估了单独或与头孢他啶合用时健康受试者中avibactam的安全性和药代动力学。

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《Clinical drug investigation》 |2015年第5期|共11页
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Merdjan Henri; Rangaraju Manickam; Tarral Antoine;
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Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-Controlled Studies

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