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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT02743260
Eligibility Criteria:
Inclusion Criteria:
* Caucasian
* Body mass index (BMI) between and inclusive 18.5 and 30 kg/m2
* Willing and capable to confirm written consent prior to enrolment after ample information has been provided
* Normal findings in the medical history unless the principal investigator considers an abnormality to be clinically relevant.
* Considered to be healthy by the principal investigator on the basis of extensive pre-study screening-
Exclusion Criteria:
Standard for healthy volunteers, including:
* Female subjects only: positive results in pregnancy test
* Female subjects only: lactating women
* Female subjects only: subjects who do not use or do not agree to use appropriate contraceptive methods during the study as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (CHMP/ICH/286/95 modification)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02743260
Study Brief:
Protocol Section:
NCT02743260