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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT01501435
Eligibility Criteria:
Inclusion Criteria:
* Male volunteers in the age between 20 and 55 years old
* BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
* Subject with no history of any significant chronic disease
Exclusion Criteria:
* History of clinically significant allergies, including fenofibric acid or Fenofibrate
* History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
* History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
* Clinical laboratory test values are outside the accepted normal range
* AST(ASpartate Transaminase), ALT(ALanine Transaminase)( \> 1.25 times to normal range
* Total bilirubin \> 1.5 times to normal range
* BUN(Blood Urea Nitrogen) \> 25 mg/dL or Creatinine \> 1.4 mg/dL
* CK(Creatine Kinase) \> 1.25 times to normal range
* Estimated GFR(Glomerular Filtration Rate) \< 80 mL/min/1.73m2
* Clinically significant vital sign
* SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
* DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
* History of drug abuse or positive urine screen for drugs
* History of caffeine, alcohol, smoking abuse
* caffeine \> 5 cups/day
* alcohol \> 201g/week
* smoking \> 10 cigarettes/day
* Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
* Participated in a previous clinical trial within 60 days prior to dosing
* Donated blood within 60 days prior to dosing
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01501435
Study Brief:
Protocol Section:
NCT01501435