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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02306902
Eligibility Criteria:
Inclusion Criteria:
Volunteers who met the following criteria were included in the study
* Were in the age range of 18-45 years.
* Were neither overweight nor underweight for his height as per the Life Insurance
* Corporation of India height/weight chart for non-medical cases.
* Had voluntarily given written informed consent to participate in this study.
* Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
* Had a non-vegetarian dietary habit.
Exclusion Criteria:
* Subject had history of hypersensitivity to fenofibrate or any related drug or to any other drug.
* Subjects with history of hepatic or severe renal dysfunction, including primary biliary cirrhosis.
* Subjects with history of unexplained persistent liver function abnormality.
* Subjects with history of preexisting gallbladder disease.
* Subject had history of myalgia, muscle tenderness or weakness or myopathy
* Subject had any evidence of organ dysfunction or any clinically significant deviation from the normal in physical or clinical determinations.
* Clinically abnormal ECG or Chest X-ray, or hematological and biochemical parameters which was/were outside acceptable limits and was judged clinically significant by investigator.
* Investigations with blood samples of the subject showed presence of disease markers of HIV 1 or 2, Hepatitis B or C Viruses of syphilis infection.
* Investigations with urine samples of the subject showed clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4 /HPF), glucose (Positive) or Protein (Positive).
* Subject had history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes, glaucoma, any serious, potentially life-threatening illness.
* Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that might impair the ability to provide, written informed consent.
* Subject was a regular smoker, who smoked 10 or more cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
* Subject had history of drug dependence or excessive alcohol intake on a habitual basis or has difficulty in abstaining for the duration of each study period.
* Use of any regular medication (OTC or prescription) or any drug metabolizing enzyme within 30 days prior to Day 1 of this study.
* Subject had participated in a clinical trial within 12 weeks preceding admission of this study (except for the subjects who dropout/withdrawn from the previous study prior to period I dosing).
* Subject had donated and/or lost more than 350 mL of blood in the past 3 months, including blood loss in this study.
* Consumption of alcohol for 48 hours prior to admission.
* Consumption of grapefruit juice and or grape fruit supplements containing products for 48 hours prior to admission.
* Subject had problem(s) in complying with the study protocol.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02306902
Study Brief:
Protocol Section:
NCT02306902