farmacokinetiek van paracetamol, niet specifiek tbv een/meerdere aandoeningen not applicable (see C21)
Conditions
Interventions
This study consists of three sequential interventions (n=9 subjects per
intervention). The order of the interventions is determined by random
assignment. Subjects will receive a single oral administ
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy (determined by an experienced physician) male of 18 years or older at the time of signing the informed consent - Normal renal and liver function - capable of giving written informed consent and to comply with the requirements and restrictions listed in the informed consent form
Exclusion criteria
Exclusion criteria: - Major illness in the past 3 months - gastrointestinal disease which may influence drug absorption -abnormalities in ASAT/ALAT/bilirubin/gammaGT/AF laboratory data -drug abuse or alcoholism (>3 units of alcohol per day) - participation in another clinical trial in the past 12 months - difficulty in donating blood or limited accessibility of a vein - use of tobacco products (induction liver enzymes) - (chronic) use of medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoint is the difference in area under the plasma concentration versus time curve (AUC) for acetaminophen and six of its metabolites following the administration of the medication after 36 hours of starvation or after three days of a high fat diet in comparison with the control situation of an overnight fast. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the difference in the PK parameters clearance, volume of distribution, absorption rate, mean residence time and elimination half-life. Furthermore, the effect of short term starvation and high fat diet in combination with APAP administration on glutathione metabolism will be studied. | — |
Countries
Netherlands
Outcome results
None listed