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

NCT02250976 | Completed Phase 1

• 1 other identifier: HL-PIF-103
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Livasupril Cap.160/2mg

EXPERIMENTAL

* Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg * once a day

Drug: Livasupril Cap.160/2mg

Lipilfen cap.160mg, Livaro tab. 2mg

ACTIVE COMPARATOR

* Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg * Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day

Drug: Lipilfen cap. 160mg; Drug: Livaro tab. 2mg

Interventions

Livasupril Cap.160/2mg DRUG

Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg

Livasupril Cap.160/2mg

Lipilfen cap. 160mg DRUG

Micronized fenofibrate 160mg

Lipilfen cap.160mg, Livaro tab. 2mg

Livaro tab. 2mg DRUG

Pitavastatin Ca 2mg

Lipilfen cap.160mg, Livaro tab. 2mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Study Officials

• Young-Ran Yoon, M.D., Ph.D.

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

KR (1)