The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250976
• Other study ID #: HL-PIF-103
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Male Volunteers

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