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:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT04311268
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female,
* Between 18 and 40 years of age for the WP I and II phases, and between 18 and 80 years of age for the WP III phase,
* Having an BMI within the range \[18.5; 24.9\] kg/m² for the Work Package I and II phases, and between \[18.5; 34.9\] kg/m² for the Work Package III phase,
* Beneficiary of the social security,
* Provided informed consent for participation in the study.
Exclusion Criteria:
* Presenting an acute pathology,
* Chronic pathology not followed and balanced,
* Having intestinal disorders (diverticles, disorders of the motility of the digestive tract, ...) or having undergone surgery at the gastrointestinal level,
* With known swallowing disorders,
* Having an alcohol dependence (more than 28 alcohol units per week), benzodiazepines or any illicit product,
* Smoking more than 5 cigarettes per day,
* Working nights or shift work,
* Simultaneous participation in other clinical research or participation in another clinical study for which the exclusion period has not ended.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04311268
Study Brief:
Protocol Section:
NCT04311268