NCT02534753已完成1 期
A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics of Intravenous Ascorbic Acid in Healthy Male and Female 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
- 8
- 试验地点
- 1
- 主要终点
- Concentration of Ascorbic Acid (µM) in plasma
研究概览
简要总结
This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic Acid.
详细描述
The objectives of this study are:
- To evaluate the single-dose pharmacokinetics of AA administered intravenously (IV).
- To evaluate the safety and tolerability of AA administered intravenously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is between the ages of 18 and 45 years, inclusive.
- •Has a body mass index (BMI) between 18 and 32 kg/m
- •Of sound health and has the ability to understand the requirements of the study and is willing to comply with all study requirements and procedures.
排除标准
- •Participates in activities that would not allow accurate evaluation of the pharmacokinetics of Ascorbic Acid
- •Medical or physical conditions that would not allow safe participation and/or accurate evaluation of the pharmacokinetics of Ascorbic Acid
- •Has participated in an investigational drug study within the 30 days prior to CRU admission.
研究组 & 干预措施
Single Group
Experimental
干预措施: Ascor L 500® (Ascorbic Acid Injection, USP) (Drug)
结局指标
主要结局
Concentration of Ascorbic Acid (µM) in plasma
时间窗: 1 day
次要结局
- Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system(1 day)
- Changes from Baseline in clinical laboratory and vital signs to discharge(1 day)
- Changes from pre-dose physical exam findings to discharge(1 day)
研究者
研究点 (1)
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