Bioequivalence Study of CJ-30060 in Healthy 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 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 volunteers.

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

Conditions
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Healthy Subjects

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged 20 to 45 years at screening BMI: 18 29.9kg/㎡ 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 28days 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) × 2 Total bilirubin > UNL × 1.5 CrCL < 50mL/min CPK > UNL × 2.5 Subjects with clinically significant low blood pressure at screening test(systolic blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg) Subjects with any positive reaction in HBsAg, 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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All

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 5/160mg, Crestor® tab 10mg period 2: receive CJ-30060 5/160/10mg | Drug: Exforge® tab 5/160mg, Crestor® tab 10mg<br>* co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg<br>Drug: CJ-30060 5/160/10mg<br>* Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg<br>|
| Experimental: Sequence 2<br>period 1: receive CJ-30060 5/160/10mg period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg | Drug: Exforge® tab 5/160mg, Crestor® tab 10mg<br>* co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg<br>Drug: CJ-30060 5/160/10mg<br>* Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg<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 48 hours post-dose | 
| Cmax of rosuvastatin |  | Up to 72 hours post-dose | 
| AUClast of amlodipine |  | Up to 144 hours post-dose | 
| AUClast of valsartan |  | Up to 48 hours post-dose | 
| AUClast of rosuvastatin |  | Up to 72 hours post-dose | 

Secondary Outcome Measures

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