Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers

Study Overview
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Brief Summary
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To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

Detailed Description
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The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

Official Title
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Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects

Conditions
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Hypertension, Hyperlipidemias

Intervention / Treatment
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* Drug: CJ-30060
* Drug: Exforge tab 5/160mg, Crestor tab 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male aged 20 to 45 years at the screening Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive) Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions. Exclusion Criteria: Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease. Subject who have symptoms, result from acute disease within 28days before first administration. Subject who have chronic persisting disease with clinical significance. Subject who fall under the criteria below in laboratory test. AST/ALT > UNL (upper normal limit) x 2 Total bilirubin > UNL x 1.5 In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault CPK > UNL x 2.5 Subject who with low blood pressure with clinical significance at screening test. (systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg) Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.

Ages Eligible for Study
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Minimum Age: 20 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: CJ-30060<br>Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg | Drug: Exforge tab 5/160mg, Crestor tab 10mg<br>* Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg<br>|
| Active Comparator: Exforge tab 5/160mg, Crestor tab 10mg<br>Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg | Drug: CJ-30060<br>* Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin |  | Up to 144 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin |  | Up to 144 hours post-dose | 
| Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin |  | Up to 144 hours post-dose | 
| Half life (t1/2) of amlodipine, valsartan, rosuvastatin |  | Up to 144 hours post-dose | 
| Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin |  | Up to 144 hours post-dose | 
| Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin |  | Up to 144 hours post-dose |