A study on the influence of alcohol on the effect of pain relievers on ventilation in two groups of volunteers: young (18-40 years) and elderly (> 75 years)
- Conditions
- Respiratory depressionTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-002797-42-NL
- Lead Sponsor
- eiden University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method