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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT01210794
Eligibility Criteria:
Inclusion criteria:
1. Male or female of 18 to 45 years old
2. Body Mass Index in the range of 19 to 25
3. No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study
Exclusion criteria:
1. Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
2. Long-term medication during the whole study (except for contraceptives)
3. Smoking
4. Pregnancy
5. Lactating
6. Earlier participation in any other clinical study within the last 30 days
* Subject Withdrawal:
* Incomplete consumption of test meal
* Missing of test meal Missing of iv dose
* Incomplete urine collection (studies 2-6); exceptions to be discussed for study 1
* No blood sample at start of study
* Consumption of food within 3 hours after iv dose - to be evaluated
* Vomiting within 3 hours after test meal administration - to be evaluated
* Sick subjects and subjects taking any medication during study - to be evaluated (postponement of test meal possible)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01210794
Study Brief:
Protocol Section:
NCT01210794