Effect of nutritional conditioning on the pharmacokinetics of acetaminophe

Completed

Conditions: farmacokinetiek van paracetamol, niet specifiek tbv een/meerdere aandoeningen
not applicable (see C21)

Registration Number: NL-OMON38549

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint is the difference in area under the plasma concentration<br /><br>versus time curve (AUC) for acetaminophen and six of its metabolites following<br /><br>the administration of the medication after 36 hours of starvation or after<br /><br>three days of a high fat diet in comparison with the control situation of an<br /><br>overnight fast. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the difference in the PK parameters clearance,<br /><br>volume of distribution, absorption rate, mean residence time and elimination<br /><br>half-life. Furthermore, the effect of short term starvation and high fat diet<br /><br>in combination with APAP administration on glutathione metabolism will be<br /><br>studied. </p><br>