Bioequivalence Study of CJ-30060 in Healthy 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® 10/160mg, Crestor® 20mg 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® 10/160mg, Crestor® 20mg in healthy male volunteers.

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: Exforge® tab 10/160mg, Crestor® tab 20mg
* Drug: CJ-30060 10/160/20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males aged 20 to 45 years at screening BMI: 18   29.9kg/m^2 Body weight ≥ 50kg Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding Exclusion Criteria: Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease Subjects who have symptoms of an acute disease within 28 days before first administration Subjects who have clinically significant active, chronic disease Subjects who fall under the criteria below in laboratory test AST/ALT > UNL (upper normal limit) x 2 Total bilirubin > UNL x 1.5 CrCL < 50mL/min CPK > UNL x 2.5 Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg) Subjects 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: Sequence 1<br>Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg Period 2: receive CJ-30060 10/160/20mg | Drug: Exforge® tab 10/160mg, Crestor® tab 20mg<br>* Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg<br>Drug: CJ-30060 10/160/20mg<br>* Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg<br>|
| Experimental: Sequence 2<br>Period 1: receive CJ-30060 10/160/20mg Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg | Drug: Exforge® tab 10/160mg, Crestor® tab 20mg<br>* Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg<br>Drug: CJ-30060 10/160/20mg<br>* Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of amlodipine |  | Up to 144 hours post-dose | 
| Cmax of valsartan |  | Up to 144 hours post-dose | 
| Cmax of rosuvastatin |  | Up to 144 hours post-dose | 
| AUClast of amlodipine |  | Up to 144 hours post-dose | 
| AUClast of valsartan |  | Up to 144 hours post-dose | 
| AUClast of rosuvastatin |  | Up to 144 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of amlodipine, valsaran, rosuvastatin |  | Up to 144 hours post-dose |