A Micro Dose Study With 14C Paracetamol, In A Single Dose Two Way Cross-Overdesign With And Without Propranolol In Six Healthy Male Volunteers
- Conditions
- evaluatie AMS technologieN/A
- Registration Number
- NL-OMON36915
- Lead Sponsor
- TNO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
- Men, healthy, aged 18 to 45 years
- Non-smoking
- BMI between 18 and 25 kg/m2, inclusive
- Body temperature, between 35.0ºC and 37.5ºC
- Systolic blood pressure, 90 to 150 mm Hg
- Diastolic blood pressure, 45 to 90 mm Hg
- Pulse rate, 40 to 100 bpm
- Subject has or had, in the opinion of the investigator, clinical significant abnormalities as found in the medical history, physical examination, electrocardiogram (ECG), laboratory profile and/or blood and urine.
- Presence or history of clinically significant psychiatric diseases, as judged by the investigator.
- Gilbert's syndrome, liverfailure or -dysfunction.
- Any clinically relevant acute or chronic diseases which according to the investigator could interfere with the subject*s safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
- Presence or history of clinically significant allergy or known hypersensitivity to any component of the investigational product.
- Enrolment in any investigational study or intake of an investigational drug within 3 months prior to the start of the study or more than 4 times a year.
- Current regular user of any illicit drugs or history of drug abuse. Subjects who have a positive drug screen at screening will be excluded.
- Donation of blood/plasma outside limits of Sanquin Blood Supply Foundation guidelines.
- Is not likely to co-operate in the study, and/or has poor compliance as anticipated by the investigator
- History of alcohol abuse and/or excessive current use of alcohol (i.e., regular use of more than 21 units of alcohol/week for males), and/or unwillingness or unable to refrain from products containing alcohol from 1 days before admission and during the stay in the research unit.
- Subjects who have a positive alcohol breath test at screening will be excluded.
- Daily consumption of xanthine-containing products more than 8 units.
- Unwilling or unable to refrain from consumption of xanthine-containing foods or drinks from 2 days prior to admission and during the stay in the research unit.
- Medication used within 7 days before both and during studydays.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics of 14C-Paracetamol in blood and urine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics of propranolol in blood serum.</p><br>