Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects

Official Title
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An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cresto 20mg
* Drug: Fenofibric acid 135mg
* Drug: Cresto 20mg, Fenofibric acid 135mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male volunteers aged 19 to 45 years A sybject who has judged to be healthy by the investigator to participate in this study based on screening result A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints Exclusion Criteria: A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history. A subject who shows the following result in clinical laboratory test AST, ALT > 1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 500 msec Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>multiple dose of Rosuvastatin 20mg | Drug: Cresto 20mg<br>* tablet, rosuvastatin 20mg<br>|
| Experimental: Fenofibric acid<br>multiple dose of Fenofibric acid 135mg | Drug: Fenofibric acid 135mg<br>* capsule, fenofibric acid 135mg<br>|
| Experimental: Rosuvastatin + Fenofibric acid<br>multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg | Drug: Cresto 20mg, Fenofibric acid 135mg<br>* rosuvastatin 20mg, Fenofibric acid 135mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | 
| AUCtau |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmin |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | 
| Tmax |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | 
| CL/F |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | 
| T1/2 |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | 
| Metabolic Ratio |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |