Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae Pharm. through 3 period by separately or combinedly.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: micronized fenofibrate
|
Drug: micronized fenofibrate 160mg
Other Names:
|
| Experimental: pitavastatin Ca
|
Drug: pitavastatin Ca 2mg
Other Names:
|
| Experimental: micronized fenofibrate plus pitavastatin Ca
|
Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Years 20-55
-
Body weight≥50kg and 18≤BMI≤29kg/m2
-
Volunteer
Exclusion Criteria:
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Subject with serious active cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
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Subject with symptoms of acute disease within 28days prior to study medication dosing
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Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
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Subject with clinically significant active chronic disease
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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
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Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, venereal disease research laboratory test
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Use of any prescription medication within 14 days prior to study medication dosing
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Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
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Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
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Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid or statin
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gallbladder disease
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Subject who experiences photo-allergy or photo-toxicity during administrating fibrates or ketoprofen
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Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
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Subject who is not albe to taking the institutional standard meal
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Subject with whole blood donation within 60days, component blood donation within 20days
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Subjects receiving blood transfusion within 30days prior to study medication dosing
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Participation in any clinical investigation within 60days prior to study medication dosing
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 700-721 |
Sponsors and Collaborators
- Hanlim Pharm. Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HL-PIF-101