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The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Livalo fixed combination drug | Experimental | Livalo fixed combination drug(Pitavastatin + Valsartan) |
|
| Pitavastatin + Valsartan | Active Comparator | Pitavastatin, Valsartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livalo fixed combination drug | Drug | Pitavastatin 4mg / Valsartan 160mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and AUC of study drugs after single oral administration | 0-48hrs |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of study drugs after single oral administration | 0-48hrs | |
| t1/2β of study drugs after single oral administration | 0-48hrs | |
| Tmax of study drugs after single oral administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun Seop Bae, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Pitavastatin, Valsartan |
| Drug |
Pitavastatin 4mg, Valsartan 160mg |
|
|
| 0-48hrs |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |