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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02250976
Other study ID # HL-PIF-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2014
Est. completion date October 2014

Study information

Verified date August 2018
Source Hanlim Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Livasupril Cap.160/2mg
Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
Lipilfen cap. 160mg
Micronized fenofibrate 160mg
Livaro tab. 2mg
Pitavastatin Ca 2mg

Locations

Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (1)

Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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