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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01109758
Eligibility Criteria:
Inclusion Criteria:
* Male or female,
* To be aged 40-65 years,
* To be post menopausal female not receiving hormone replacement therapy,
* To have normal homocysteine, folate and vitamin B12 levels at baseline (results available for initiation of treatment),
* To be in good health as determined by medical history, physical examination, ECG, vital signs, serum/urine biochemistry and hematology.
Exclusion Criteria:
* Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, neurologic/psychiatric or emotional, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, (drug) allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the study medication,
* Subjects who have been treated with fenofibrate in a previous study,
* Subjects who have taken a single dose of an investigational drug within 30 days or multiple doses of any investigational drug within 60 days prior to dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01109758
Study Brief:
Protocol Section:
NCT01109758