Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin

NCT01767610 | Completed Phase 1

• 1 other identifier: HL-PIF-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg and Livalo tab. 2mg through 3 period by separately or combinedly.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (1)

• Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss)

  just before dosing on 1st day and 4th day of each period and 0, 0.25, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48hr on final 5th dosing

Secondary Outcomes (1)

• Number of participants with adverse events

  Participants will be followed for the duration of study medication dosing days and hospital stay, and expected average of 3days and follow-up period for maximum 7 days from the discharge

Study Arms (3)

micronized fenofibrate

EXPERIMENTAL

Drug: micronized fenofibrate 160mg

pitavastatin Ca

EXPERIMENTAL

Drug: pitavastatin Ca 2mg

micronized fenofibrate plus pitavastatin Ca

EXPERIMENTAL

Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg

Interventions

micronized fenofibrate 160mg DRUG

Also known as: Lipilfen cap. 160mg : once daily for 5 days

micronized fenofibrate

pitavastatin Ca 2mg DRUG

Also known as: Livalo tab. 2mg : once daily for 5 days

pitavastatin Ca

micronized fenofibrate 160mg plus pitavastatin Ca 2mg DRUG

Also known as: Lipilfen cap. 160mg plus Livalo tab. 2mg : once daily for 5 days

micronized fenofibrate plus pitavastatin Ca

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Years 20-55
• Body weight≥50kg and 18≤BMI≤29kg/m2
• Volunteer

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, 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 albe 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

MeSH Terms

Interventions

Fenofibrate; pitavastatin

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Design

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

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 14, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

KR (1)