NCT01579526已完成1 期
A Randomized, Single Dose Study to Determine the Safety and Pharmacokinetics of FP01 Lozenges in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetic profiles of the active pharmaceutical ingredient
研究概览
简要总结
The purpose of this study is to determine the safety and pharmacokinetics of FP01 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FP01 Dose 1
Experimental
Drug
干预措施: FP01 (Drug)
FP01 Dose 2
Experimental
Drug
干预措施: FP01 (Drug)
FP01 Dose 3
Experimental
Drug
干预措施: FP01 (Drug)
Comparator
Active Comparator
Drug
干预措施: FP01 (Drug)
结局指标
主要结局
Plasma pharmacokinetic profiles of the active pharmaceutical ingredient
时间窗: various timepoints over 72 hours
Plasma PK profiles: various PK indices including, but not limited to, peak plasma concentration (Cmax), Area under the plasma concentration versus time curve (AUC), and elimination half-life (T1/2), and time to peak plasma concentration (Tmax).
Safety and Tolerability
时间窗: Various Timepoints over 72 Hours
Safety and Tolerability will take into account the recorded AEs, vital signs, and clinical and laboratory assessments.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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