Healthy Male Volunteers Clinical Trial
Official title:
A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers
Verified date | August 2018 |
Source | Hanlim Pharm. Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.
Status | Completed |
Enrollment | 41 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy male subjects age 19 to 55 at the screening visit - Body weight=50kg and within Ideal body weight±20% - Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis - Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study Exclusion Criteria: - Subject with serious active cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease - Subject with symptoms of acute disease within 28days prior to study medication dosing - Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug - Subject with clinically significant active chronic disease - Subject with any of the following conditions in laboratory test i. AST(aspartate aminotransferase) or ALT(alanine transferase) > upper normal limit × 1.5 ii. Total bilirubin > upper normal limit × 1.5 iii. renal failure with Creatinine clearance < 50mL/min iv. creatine phosphokinase > upper normal limit × 2 - Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, human immunodeficiency virus antigen/antibody,venereal disease research laboratory test - Use of any prescription medication within 14 days prior to study medication dosing - Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing - Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) - Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid or statin - gallbladder disease - Subject who experiences photo-allergy or photo-toxicity during administrating fibrates or ketoprofen - Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption - Subject who is not able to taking the institutional standard meal - Subject with whole blood donation within 60days, component blood donation within 20days - Subjects receiving blood transfusion within 30days prior to study medication dosing - Participation in any clinical investigation within 60days prior to study medication dosing - Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day) - Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyungpook National University Hospital | Daegu |
Lead Sponsor | Collaborator |
---|---|
Hanlim Pharm. Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUClast(area under the curve) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | ||
Primary | Cmax(maximum concentration) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | ||
Primary | AUClast(area under the curve) of pitavastatin | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | ||
Primary | Cmax(maximum concentration) of pitavastatin | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | ||
Secondary | AUCinf(area under the curve) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | ||
Secondary | Tmax(time to Maximum Plasma Concentration) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | ||
Secondary | t1/2(half life) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | ||
Secondary | AUCinf(area under the curve) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | ||
Secondary | Tmax(time to Maximum Plasma Concentration) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | ||
Secondary | t1/2(half life) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | ||
Secondary | Number of participants with adverse events | Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge |
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