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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05112133
Eligibility Criteria:
Inclusion Criteria:
* Male and female participants
* Healthy status (based on anamnesis)
* Age between 18 and 45 years
* BMI between 20 and 29.9 kg/m2
* Ability to understand and sign an informed consent form
Exclusion Criteria:
* Pregnant or lactating women
* Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
* Known food allergy and intolerance to test product
* Medically known cutaneous hypersensitivity to adhesives and plasters
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
Smokers
Volunteer who cannot be expected to comply with the protocol
Subject having a hierarchical link with the research team members.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05112133
Study Brief:
Protocol Section:
NCT05112133