The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001258
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 40
1) Healthy male subjects age 19 to 55 at the screening visit
2) Body weight=50kg and within Ideal body weight±20%
3) Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis and
4) Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study
1) Subject with serious active cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
2) Subject with symptoms of acute disease within 28days prior to study medication dosing
3) Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
4) Subject with clinically significant active chronic disease
5) Subject with any of the following conditions in laboratoy test
i. AST(aspartate aminotransferase)or ALT(alanine transferase) > upper normal limit X 1.5
ii. Total bilirubin > upper normal limit X 1.5
iii. Renal failure with creatinine clearance <50mL/min
iv. Creatinin phsphokinase > upper normal limit X 2
6) Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, human immunodeficiency virus antigen/antibody,venereal disease research laboratory test
7) Use of any prescription medication within 14 days prior to study medication dosing
8) Use of any medication such as over-the-cunter medication including oriental medication within 7 days prior to study medication dosing
9) Subject with clinically significant allergic disease(except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
10) Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid and statin
11) Gallbladder disease
12) Subject aho experiences photo-allergy or photo-toxicity during administrating fibrates and ketoprofen
13) Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
14) Subject who is not able to taking the institutional standard meal
15) Subject with whole blood donation within 60days, component blood donation within 20days
16) Subjects receiving blood transfusion within 30days prior to study medication dosing
17) Participation in any clinical investigation within 60days prior to study medication dosing
18) Continued excessive use of caffeine(caffeine>five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette>10 cigarettes/day)
19) Subjects with decision of nonparticipation through inverstigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClase, Cmax
- Secondary Outcome Measures
Name Time Method AUCint, Tmax, t1/2;Number of participants with adverse events