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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.
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.
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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 5/160mg, Crestor® tab 10mg | Drug | co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of amlodipine, valsartan, 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 28days 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 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo-Sook Seo | Contact | 82-2-6477-0262 | hs.seo1@cj.net | |
| Min-ja Kang | Contact | 82-2-6477-0260 | minja.kang@cj.net |
| Name | Affiliation | Role |
|---|---|---|
| Ji Young Park, PhD | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | 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 5/160/10mg | Drug | Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg |
|
| 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 |