NL-OMON40452招募中不适用
Alcohol and Oxycodone - The influence of the combination of alcohol and an opioid on ventilation in healthy young and elderly volunteers - the 'A&O' study - A&O study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Healthy sybjects
- •- Aged 18-40 years (phase I)
- •- Aged 65 years or older (phase II)
- •- Body Mass Index 18-35 mm/kg2
- •- Subject is able to read and understand the written consent form, complete study related procedures and communicate with the study staff
- •- Healthy and free of significant abnormale findings as determined by medical history, physical examination and vital signs. For the elderly volunteers no abnormal findings for kidney and liver function on laboratory tests.
- •- Subject is deemed suitable by the Investigator for inclusion in the study
排除标准
- •Current diagnosis or history of psychiatric disease
- •Current or chronic medical condition requiring the medication considered Cytochrome P-450 (CYP2E1, CYP2D6, CYP3A4) inductor or current use of opioid analgesics
- •Current diagnosis or history of lung disease (i.e. asthma, COPD, tuberculosis)
- •Exclusion based on medication use is subject to jugdment by investigators
- •Participation in a clinical drug study during the 60 days preceding the initial dosing of this study
- •Any history of frequent nausea or vomiting regardles of etiology
- •Weekly alcohol intake exceeding the equivalent of 21 units/week or positive alcohol breath test during check-in
- •Asian ethnicity
研究者
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