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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-30060 | Experimental | Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg |
|
| Exforge tab 5/160mg, Crestor tab 10mg | Active Comparator | Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-30060 | Drug | Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin | Up to 144 hours post-dose |
| 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 |
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Inclusion Criteria:
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.
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)
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| Name | Affiliation | Role |
|---|---|---|
| Ji Young Park, PhD | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Exforge tab 5/160mg, Crestor tab 10mg | Drug | Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg |
|
| 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 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D017311 | Amlodipine |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |