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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1(RTR) | Experimental |
| |
| Sequence 2(RRT) | Experimental |
| |
| Sequence 3(TRR) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-30061 | Drug | Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| tmax of amlodipine | Up to 72 hours | |
| tmax of valsartan | Up to 72 hours | |
| tmax of atorvastatin |
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Inclusion Criteria:
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.
Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)
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| Name | Affiliation | Role |
|---|---|---|
| JaeWook Ko, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | 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 |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Exforge® 5/160mg & Lipitor® 20mg | Drug | Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg |
|
| 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 |
| 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 |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |