Study on Pharmacokinetics of Moxifloxacin in Serum and Liver Tissue of Patients Undergoing Liver Resection Due to Primary or Secondary Tumor of the Liver
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Concentration (mg/L) of moxifloxacin in liver tissue
研究概览
简要总结
The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.
详细描述
After given informed consent, patients scheduled for planned liver resection are enrolled into the study. The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. Blood and healthy liver tissue are sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36 and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying a two-compartment model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years old
- •elective liver resection of liver tumor
- •in females: pregnancy test negative
- •Subjects willing and able to give fully informed written consent
排除标准
- •subjects with contra-indications to Moxifloxacin
- •subjects under therapy with Moxifloxacin within 2 weeks before recruitment
研究组 & 干预措施
Moxifloxacin
Moxifloxacin 400 mg i.v.
干预措施: Moxifloxacin 400 mg (Drug)
结局指标
主要结局
Concentration (mg/L) of moxifloxacin in liver tissue
时间窗: 1.5 hours after moxifloxacin infusion
The first outcome of this study was to analyze the concentration of MFX in liver tissue of patients who received MFX 400 mg i.v..
次要结局
- Maximum concentration (mg/L) of moxifloxacin in serum(at the end of intravenous infusion)
- Number of participants with adverse events(48 hours)
- Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L)(48 hours)