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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Delafloxacin Pharmacokinetics in Subjects With Varying Degrees of Renal Function
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Delafloxacin Pharmacokinetics in Subjects With Varying Degrees of Renal Function

机译：具有不同程度的肾功能受试者的Delafloxacin药代动力学

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Abstract Delafloxacin, a fluoroquinolone, has activity against gram‐positive organisms including methicillin‐resistant Staphylococcus aureus and fluoroquinolone‐susceptible and –resistant gram‐negative organisms. This study was conducted to determine delafloxacin pharmacokinetics after a single intravenous infusion or oral dose administration in subjects with varying degrees of renal function. The study was an open‐label, parallel‐group crossover study in subjects with normal renal function or with mild, moderate, or severe renal impairment. Subjects received 300?mg delafloxacin intravenously, placebo intravenously, and 400?mg delafloxacin orally in 3 periods separated by ≥14‐day washouts. Blood and urine pharmacokinetic parameters were calculated using noncompartmental methods. Delafloxacin total clearance decreased with decreasing renal function, with a corresponding increase in AUC 0–∞ . After intravenous administration, mean total clearance was 13.7 and 7.07 L/h, and mean AUC 0–∞ was 22.6 and 45.0 μg·h/mL in normal and severe renal subjects, respectively. Mean renal clearance as determined by urinary excretion was 6.03 and 0.44 L/h in normal and severe renal impairment subjects, respectively. Total clearance exhibited linear relationships to eGFR and CL CR . Similar observations were found after oral administration of delafloxacin. Single doses of delafloxacin 300?mg intravenously and 400?mg orally were well tolerated in all groups. In conclusion, renal insufficiency has an effect on delafloxacin clearance; a dosing adjustment for intravenous dosing is warranted for patients with severe renal impairment (eGFR 30 mL/min).
机译：氟代喹啉，氟代喹啉，氟氮喹啉，对革兰蛋白抗葡萄球菌和氟喹诺酮类易感和 - 腐蚀剂革兰氏阴性生物体的活性抗革氏喹啉酮活性。该研究进行了在具有不同程度的肾功能的受试者中静脉内输注或口服剂量给药后确定Delafloxacin药代动力学。该研究是肾功能正常或温和，中度或重度肾损伤的受试者的开放标签，并联组交叉研究。受试者在静脉内，安慰剂静脉内接受300？Mg Delafloxacin，并在3个时期口服400毫克德拉昔洛辛酸，其分离≥14天的冲洗剂。使用非组分方法计算血液和尿药代动力学参数。 Delafloxacin通过降低的肾功能下调降低，AUC 0-Ⅵ的相应增加。静脉内给药后，平均完全间隙是13.7和7.07升/小时，并且平均AUC 0-Ⅳ分别为正常和重度肾受试者的22.6和45.0μg·h / ml。在正常和重度肾脏损伤受试者中，尿排尿所确定的平均肾间隙分别为6.03和0.44升/小时。总间隙表现出与EGFR和CL CR的线性关系。在Delafloxacin口服施用后发现类似的观察结果。单剂量的Delafloxacin 300？Mg静脉内，400μg口服在所有基团中耐受良好。总之，肾功能不全对Delafloxacin清除有影响;对于严重肾损伤的患者（EGFR＆LT; 30ml / min），有必要对静脉注射剂量进行给药调整。

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