Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00928733
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form.
* Male gender to avoid the gender-related differences in ethanol metabolism.
* Between 18-45 years to avoid age-related changes in ethanol metabolism39.
* Normal medical history and physical examination.
* Normal liver function tests (i.e. ALT, AST, and γGT) according to the reference values for normal ranges of the liver enzymes at the laboratory of clinical chemistry of the Maastricht University Medical Center.
* Caucasian ethnicity.
* BMI=18 - 30 kg/m2.
Exclusion Criteria:
* History of gastro-intestinal disorders or abdominal surgery.
* History of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)40.
* Recent or chronic medications that may interact with ethanol metabolism or intestinal permeability i.e., NSAIDs, benzodiazepines and antidepressants.
* Smoking.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00928733
Study Brief:
Protocol Section:
NCT00928733