CKD-391 Pharmacokinetic Study Phase I

Study Overview
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Brief Summary
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A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

Detailed Description
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To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial. Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Official Title
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Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CKD-391
* Drug: Atrovastatin and Ezetimibe combination therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bwt >=50kg, BMI 18.5 25 signed the informed consent form prior to the study participation Exclusion Criteria: - Clinically significant disease Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug Clinically significant allergic disease Impossible to taking the institutional standard meal Previously donate whole blood within 60 days or component blood within 20 days Previously participated in other trial within 90 days Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials An impossible one who participates in clinical trial by investigator's decision including laboratory test result

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR group<br>CKD-391 and combination dose of Atrovastatin and Ezetimibe in order | Drug: CKD-391<br>* Investigational product is prescribed to all of randomized subjects for two times.<br>Drug: Atrovastatin and Ezetimibe combination therapy<br>* Investigational products are prescribed to all of radomized subjects for two times.<br>|
| Experimental: RT group<br>combination dose of Atrovastatin and Ezetimibe and CKD-391 in order | Drug: CKD-391<br>* Investigational product is prescribed to all of randomized subjects for two times.<br>Drug: Atrovastatin and Ezetimibe combination therapy<br>* Investigational products are prescribed to all of radomized subjects for two times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | up to 96 hours post dose | 
| Cmax |  | up to 96 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | up to 96 hours post dose | 
| T1/2 |  | up to 96 hours post dose | 
| AUCinf |  | up to 96 hours post dose | 
| Adverse events |  | up to 24days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, CKD-391, Atorvastatin, Ezetimibe