CKD-337 Drug Interaction Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.

Official Title
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Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers

Conditions
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Dyslipidemia (Fredrickson Type Ⅱa), Dyslipidemia (Fredrickson Type Ⅱb)

Intervention / Treatment
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* Drug: Fenofibrate
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male volunteer between 19 and 55 years old. BMI between 18.5 and 27. Able to participate in the entire trial Signed the informed consent form prior to study participation. Exclusion Criteria: Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system sit SBP < 100mmHg or sit SBP ≥ 150mmHg or sit DBP < 70mmHg or sit DBP ≥ 100mmHg Have acute infection history within 14 days Have a allergic disease of need to treat Have hypersensitivity reactions history for IP or any specific drugs. AST, ALT or Total bilirubin > UNL * 1.5 Estimated GFR < 60 ml/min Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption A heavy smoker (cigarette > 10 cigarettes per day) A heavy alcohol consumer (alcohol > 140g/week) A heavy grapefruit consumer (more than 1cup per a day) Have a history of drug abuse or showed a positive for urine drug test. Administrated IP within 60 days prior to screening Rhabdomyolysis include of having a history or family history of genetic muscle diseases Positive for HIV antibody, HBsAg, HCV antibody test Previously donate whole blood within 60 days or component blood within 30 days Subject takes ethical drug or herbal medicine within 30 days Clinically significant laboratory test result An impossible one who participates in clinical trial by investigator's decision including other reason

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenofibrate<br>Subjects received Fenofibrate | Drug: Fenofibrate<br> <br> |
| Experimental: Atorvastatin<br>Subjects received Atorvastatin | Drug: Atorvastatin<br> <br> |
| Experimental: Fenofibrate and Atorvastatin<br>Subjects received Fenofibrate and Atorvastatin | Drug: Fenofibrate<br> <br> Drug: Atorvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt, Cmax,ss of fenofibric acid and atorvastatin |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h |