NCT00210093已完成1 期
A Single-Center, Randomized, Crossover Pharmacokinetic Evaluation of the Effect of Single Doses of Intravenous INS37217, Nasally Inhaled INS37217 and Orally Inhaled 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
- 12
- 主要终点
- 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, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use
- •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, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy
- •Subject with a physical obstruction in the nose
- •Use of concomitant medication other than hormonal contraceptives and multi-vitamins
- •Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness
结局指标
主要结局
plasma concentrations of INS37217
次要结局
- Pilot study - not specified
研究者
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