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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
|
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| Sequence 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exforge® tab 10/160mg, Crestor® tab 20mg | Drug | Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of amlodipine, valsaran, rosuvastatin | Up to 144 hours post-dose |
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Inclusion Criteria:
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
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
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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 |
|---|---|
| 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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| CJ-30060 10/160/20mg | Drug | Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg |
|
| 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 |