NCT00210054已完成1 期
Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 主要终点
- detection and characterization of plasma concentrations of INS37217
研究概览
简要总结
The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.
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
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •are nonsmokers or those subjects whom have not smoked within 6 months
- •are within 20% of their ideal body weight
- •are healthy on the basis of a pre-trial physical examination
排除标准
- •history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
- •history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
- •use of concomitant medication other than hormonal contraceptives and multi-vitamins
- •donation of blood in the 60 days preceding the screening visit
- •have been diagnosed with HIV, hepatitis B or hepatitis C
结局指标
主要结局
detection and characterization of plasma concentrations of INS37217
次要结局
- Pilot study - not specified
研究者
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