None listed
Conditions
Interventions
Drug : Sequence A: Single oral administration of UI201606(Fenofibric acid 135 mg in sustained-release pellets formulation) under fasting conditions and single oral dose of UI014(Fenofibric acid 110 mg
Sponsors
Korea United Pharm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy male volunteers aged between 19 - 45 years at screening. 2.Subject who weight was = 55 kg and ideal body weight (IBW) was within ±20% [Ideal Body Weight (IBW, kg) = (Height(cm) - 100) × 0.9] 3.Subject who don’t have congenital or chronic disease and any pathologic sign or symptom from medical check-up. 4.Subject who be within normal range by clinical laboratory results such as hematology test, blood chemistry test, urine test, etc. 5.Subject who be informed of and completely understood this clinical trial and signed the written informed consent for voluntary participation.
Exclusion criteria
Exclusion criteria: 1.Subject who have a clinically significant past or present medical history of hepato-biliary, renal, respiratory, hematologic/neoplastic, urologic, psychiatric, cardiovascular (hypertension, angina, heart failure, myocardial infarction, etc.)and endocrine diseases(diabetes, hyperlipidemia). 2.Subject with a history of gastrointestinal disease (e.g. Crone’s disease, ulceration, acute or chronic pancreatitis, etc) or surgery (except simple appendectomy or repair of a hernia), which can influence the absorption of the study drug. 3.Subjects with hypersensitivity reactions to drugs like Fenofibric acid, fibrate such as bezafibrate, ciprofibrate, clofibrate, gemfibrozil. 4.Uncontrolled genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 5.Subject who was systolic blood pressure (SBP) = 140 mmHg mmHg or < 90 mmHg, diastolic blood pressure (DBP) = 95 mmHg or < 60 mmHg or pulse rate (PR) = 100 /min. 6.Subject with liver dysfunction or gallbladder disease. 7.Subject with renal dysfunction or a history. 8.Subject who was ALT (alanine aminotransferase) = 100 IU/L. 9.Subject with severe renal dysfunction(creatinine clearance with Cockroft-Gault < 30 mL/min). 10.Subject with a history of drug abuse. 11.Subject who took barbiturates or an inducer or inhibitor of drug metabolite enzymes or have consumed excessive alcohol within 1 month before the first study drug administration. 12.Subject who used ethical-the-counter drugs or herbal medicine within 2 weeks prior to the scheduled 1st study drug administration and who used over-the-counter drugs or vitamin within 10 days prior to the scheduled 1st study drug administration (But, subject whose other conditions are judged by investigators as appropriate for this clinical trial could participate in this study). 13.Subjects who has participated in any other clinical trial either for investigational or marketed drugs within 3 months prior to the scheduled 1st study drug administration. 14.Subject who donated whole blood within 2 months or blood components within 1 month before the first administration, or who received blood transfusion within 1 month before the first administration. 15.Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol from unable to refrain from drinking during within 24 hours prior to hospitalization and until discharge. 16.Smokers with an average daily smoking amount exceeding 10 cigarettes per day in recent 3 months. 17.Subjects who were judged by investigator as inappropriate to participate in the clinical trial due to the results of clinical laboratory test results or other reasons. 18.Subject who can not use contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 0-last measurable time point area under mean plasma concentration-time curve;Maximal plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 0-infinity area under mean plasma concentration-time curve;Time for the maximal plasma concentration;Half-life;Apparent Clearance | — |
Countries
Korea, Republic of
Contacts
Public ContactJae hoon Kim
Chungnam National University Hospital
Outcome results
None listed