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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT02292303
Eligibility Criteria:
Inclusion Criteria:
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Sex: female (premenopausal), male
* Age: 20 - 50 years
* BMI ≥19 or ≤30 kg/m²
* Non-smoker
* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, hematology
Exclusion Criteria:
* Relevant history or presence of any medical disorder, potentially interfering with this trial
* For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
* Migraine or regular headache, intense premenstrual symptoms
* Coffee consumption \>3 cups / day
* Blood donation within 2 months prior to trial start or during trial
* Regular intake of mineral supplements within 4 weeks prior to trial start or during trial
* Chronic intake of substances affecting the intestinal absorption of zinc
* Vegetarians / vegans
* Drug-, alcohol- and medication abuses
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Relevant allergy or known hypersensitivity against compounds of the study preparations, for example lactose intolerance
* Known pregnancy, breast feeding or intention to become pregnant during the study
* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
* Not anticipating any planned changes in lifestyle for the duration of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT02292303
Study Brief:
Protocol Section:
NCT02292303