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

eiden University Medical Centre0 个研究点开始时间: 2013年7月29日最近更新: 2013年9月30日

试验速览

暂无简介。

•- Healthy sybjects
•- Aged 18-40 years (phase I)
•- Aged 75 years or older (phase II)
•- Body Mass Index 18-30 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
•- Subject is deemed suitable by the Investigator for inclusion in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 12

•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

发起方

eiden University Medical Centre