Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Brain Concentrations of Voriconazole
研究概览
简要总结
To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must be willing and able to provide informed consent.
- •Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.
排除标准
- •Subjects with any condition affecting drug absorption.
研究组 & 干预措施
voriconazole
voriconazole twice daily
干预措施: voriconazole (Drug)
结局指标
主要结局
Brain Concentrations of Voriconazole
时间窗: Day 3: pre-dose, 2 hours post-dose
Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).
Plasma Concentrations of N-oxide Metabolite
时间窗: Day 3: pre-dose, 2 hours post-dose
Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.
Plasma Concentrations of Voriconazole
时间窗: Day 3: pre-dose, 2 hours post-dose
Mean plasma voriconazole concentrations (nanograms per milliliter \[ng/mL\]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.
Brain Concentrations of N-oxide Metabolite
时间窗: Day 3: pre-dose, 2 hours post-dose
Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).
次要结局
未报告次要终点