NCT00855101已完成1 期
An Open-Label, Intravenous (6/4 Mg/Kg Q12h) To Oral Switch (200 Mg Q12h), Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Healthy Male And Female Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults
研究概览
简要总结
This study is to assess the plasma concentration-time profile of voriconazole in adults receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to assess the safety profile of voriconazole during the treatment period.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects from 18 and 55 years old.
- •Body weight between 40 kg (88 lbs) and 100 kg (220 lbs).
排除标准
- •Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, ocular, neurologic, or allergic disease.
- •Subjects with any condition possibly affecting drug absorption, eg, gastrectomy.
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
研究组 & 干预措施
voriconazole
Experimental
干预措施: voriconazole (Drug)
结局指标
主要结局
The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults
时间窗: 14 days
次要结局
- The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults(14 days)
研究者
研究点 (1)
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