evaluatie AMS technologie N/A
Conditions
Interventions
Microdosing 14C paracetamol 100 microgram intavenous with and without
propranolol 80 milligram orally
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of 14C-Paracetamol in blood and urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of propranolol in blood serum. | — |
Countries
Netherlands
Outcome results
None listed