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Pharmacokinetics, safety, and tolerability of nacubactam (OP0595) after intravenous infusion: a randomized, double-blind, placebo-controlled phase I clinical trial in healthy Chinese male subjects.

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Title: Pharmacokinetics, safety, and tolerability of nacubactam (OP0595) after intravenous infusion: a randomized, double-blind, placebo-controlled phase I clinical trial in healthy Chinese male subjects.
Authors: Qiu H; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Wu T; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.; Department of Pharmacy, The Third Xiangya Hospital, Central South University, No.138, Tongzipo Road, Changsha, 410013, China., Diao L; Shanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China., Yu N; Shanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China., Chen H; Fobeni Healthcom Pharmaceutical Jiangsu Co., Ltd., Jiangsu, China., Peng X; Fobeni Healthcom Pharmaceutical Jiangsu Co., Ltd., Jiangsu, China., Jie Huang; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Xie J; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Wu Q; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Yang S; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Yang X; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Zeng L; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Pei Q; Department of Pharmacy, The Third Xiangya Hospital, Central South University, No.138, Tongzipo Road, Changsha, 410013, China., Guo C; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China., Yang G; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China. ygp9880@126.com.; XiangYa School of Pharmaceutical Sciences, Central South University, Changsha, China. ygp9880@126.com.; Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, No.138, Tongzipo Road, Changsha, 410013, China. ygp9880@126.com.
Source: Clinical and experimental medicine [Clin Exp Med] 2025 Dec 02; Vol. 26 (1), pp. 96. Date of Electronic Publication: 2025 Dec 02.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase I
Journal Info: Publisher: Springer-Verlag Italia Country of Publication: Italy NLM ID: 100973405 Publication Model: Electronic Cited Medium: Internet ISSN: 1591-9528 (Electronic) Linking ISSN: 15918890 NLM ISO Abbreviation: Clin Exp Med Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Pharmacokinetics, safety, and tolerability of nacubactam (OP0595) after intravenous infusion: a randomized, double-blind, placebo-controlled phase I clinical trial in healthy Chinese male subjects.
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  Data: <searchLink fieldCode="AU" term="%22Qiu+H%22">Qiu H</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Wu+T%22">Wu T</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.; Department of Pharmacy, The Third Xiangya Hospital, Central South University, No.138, Tongzipo Road, Changsha, 410013, China.<br /><searchLink fieldCode="AU" term="%22Diao+L%22">Diao L</searchLink>; Shanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Yu+N%22">Yu N</searchLink>; Shanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Chen+H%22">Chen H</searchLink>; Fobeni Healthcom Pharmaceutical Jiangsu Co., Ltd., Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Peng+X%22">Peng X</searchLink>; Fobeni Healthcom Pharmaceutical Jiangsu Co., Ltd., Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Jie+Huang%22">Jie Huang</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Xie+J%22">Xie J</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Wu+Q%22">Wu Q</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Yang+S%22">Yang S</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Yang+X%22">Yang X</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Zeng+L%22">Zeng L</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Pei+Q%22">Pei Q</searchLink>; Department of Pharmacy, The Third Xiangya Hospital, Central South University, No.138, Tongzipo Road, Changsha, 410013, China.<br /><searchLink fieldCode="AU" term="%22Guo+C%22">Guo C</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China.<br /><searchLink fieldCode="AU" term="%22Yang+G%22">Yang G</searchLink>; Central South University Third Xiangya Hospital Center of Clinical Pharmacology Changsha, Changsha, 410013, Hunan, China. ygp9880@126.com.; XiangYa School of Pharmaceutical Sciences, Central South University, Changsha, China. ygp9880@126.com.; Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, No.138, Tongzipo Road, Changsha, 410013, China. ygp9880@126.com.
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  Data: <searchLink fieldCode="JN" term="%22100973405%22">Clinical and experimental medicine</searchLink> [Clin Exp Med] 2025 Dec 02; Vol. 26 (1), pp. 96. <i>Date of Electronic Publication: </i>2025 Dec 02.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer-Verlag+Italia%22">Springer-Verlag Italia </searchLink><i>Country of Publication: </i>Italy <i>NLM ID: </i>100973405 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1591-9528 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215918890%22">15918890 </searchLink><i>NLM ISO Abbreviation: </i>Clin Exp Med <i>Subsets: </i>MEDLINE
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