Pharmacokinetics of benapenem for injection in subjects with mild to moderate renal impairment.
Objective: This study evaluated the pharmacokinetic (PK) characteristics of benapenem in subjects with mild to moderate renal impairment to provide a reference for benapenem dosing regimens in this patient population. Methods: Eighteen subjects were enrolled in this study. Each subject received a si...
| Published in: | European Journal of Clinical Pharmacology Vol. 78; no. 7; pp. 1079 - 1087 |
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| Main Authors: | , , , , , , , , , , , , , , |
| Format: | clinical trial research tables/charts Journal Article |
| Published: |
Springer Nature
Jul2022
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=157415227&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 157415227 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Jul2022 vid: 78 iid: 7 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 157415227 156158987 157415227 157415227 10.1007/s00228-022-03317-y 157415227 ppf: 1079 ppct: 8 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Pharmacokinetics of benapenem for injection in subjects with mild to moderate renal impairment. aug: au: Yang, Haijing Zhang, Min Chen, Yuancheng Ren, Hong Zhang, Hong Yu, Chen Lu, Jianda You, Li Yu, Jicheng Liang, Hong Xiao, Cuilan He, Zishuang Wu, Jufang Xue, Jun Zhang, Jing affil: Phase I Unit, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, 200040, Shanghai, China sug: subj: Kidney Diseases Drug Therapy Antibiotics, Lactam Pharmacokinetics Antibiotics, Lactam Administration and Dosage Administration, Intravenous Severity of Illness Treatment Outcomes Human Patient Safety Adverse Drug Event Drug Monitoring Clinical Trials ab: Objective: This study evaluated the pharmacokinetic (PK) characteristics of benapenem in subjects with mild to moderate renal impairment to provide a reference for benapenem dosing regimens in this patient population. Methods: Eighteen subjects were enrolled in this study. Each subject received a single dose of benapenem intravenously (1.0 g in 100 ml of 0.9% saline) followed by blood and urine collection to measure the concentrations of benapenem and its major metabolite. PK analysis was performed to evaluate the effect of varying degrees of renal impairment on the PK characteristics of benapenem. The safety of benapenem was also evaluated. Results: In subjects with normal renal function, mild renal impairment, and moderate renal impairment, the maximum plasma benapenem concentrations were 163 ± 6.58 mg/L, 138 ± 17.4 mg/L, and 134 ± 0.11 mg/L, respectively (15.3% and 17.8% lower in subjects with mild and moderate renal impairment, respectively, than in subjects with normal renal function). The areas under the plasma concentration–time curve (AUC0-inf) were 1153.67 ± 143.2 mg·h/L, 1129.17 ± 241.41 mg·h/L, and 1316.46 ± 229.83 mg·h/L, respectively (P > 0.05); the cumulative urinary excretion rates at 72 h after dosing were 52.61 ± 8.58%, 39.42 ± 8.35%, and 29.84 ± 9.15%, respectively; and the metabolic ratio (AUC0-inf_KBP-3331/AUC0-inf_benapenem) were 3.96 ± 0.35%, 5.56 ± 0.82%, and 8.24 ± 0.85%, respectively. No drug-related adverse events (AEs), serious AEs, or AEs leading to withdrawal occurred in this study. Conclusion: No adjustment to benapenem dosing is needed in patients with mild to moderate renal impairment. Clinical trial registration: Drug clinical trial registration and information publicity platform: http://www.chinadrugtrials.org.cn/index.html. Registration number: CTR20190760. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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