Bioequivalence Study of CJ-30061 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-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Official Title
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An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: CJ-30061
* Drug: Exforge® 5/160mg & Lipitor® 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male aged 19 to 55 years at the time of signing informed consent form. Subject with BMI from 19kg/m^2 to 27kg/m^2 Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study Exclusion Criteria: Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease. Subject who fall under the criteria below in laboratory test. AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5 CPK > UNL x 2.5 CrCL < 60mL/min Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1(RTR)<br> | Drug: CJ-30061<br>* Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)<br>Drug: Exforge® 5/160mg & Lipitor® 20mg<br>* Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg<br>|
| Experimental: Sequence 2(RRT)<br> | Drug: CJ-30061<br>* Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)<br>Drug: Exforge® 5/160mg & Lipitor® 20mg<br>* Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg<br>|
| Experimental: Sequence 3(TRR)<br> | Drug: CJ-30061<br>* Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)<br>Drug: Exforge® 5/160mg & Lipitor® 20mg<br>* Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 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 72 hours | 
| Cmax of valsartan |  | Up to 72 hours | 
| Cmax of atorvastatin |  | Up to 72 hours | 
| AUCt of amlodipine |  | Up to 72 hours | 
| AUCt of valsartan |  | Up to 72 hours | 
| AUCt of atorvastatin |  | Up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax of amlodipine |  | Up to 72 hours | 
| tmax of valsartan |  | Up to 72 hours | 
| tmax of atorvastatin |  | Up to 72 hours | 
| t1/2 of atorvastatin |  | Up to 72 hours | 
| t1/2 of amlodipine |  | Up to 72 hours | 
| t1/2 of valsartan |  | Up to 72 hours | 
| AUCinf of amlodipine |  | Up to 72 hours | 
| AUCinf of valsartan |  | Up to 72 hours | 
| AUCinf of atorvastatin |  | Up to 72 hours | 
| AUCt of 2-OH atorvastatin |  | Up to 72 hours | 
| Cmax of 2-OH atorvastatin |  | Up to 72 hours | 
| tmax of 2-OH atorvastatin |  | Up to 72 hours | 
| t1/2 of 2-OH atorvastatin |  | Up to 72 hours | 
| AUCinf of 2-OH atorvastatin |  | Up to 72 hours |