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The objective of this study is:
To evaluate the pharmacokinetics and safety of an experimental combination tablet containing 20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and 50 mg losartan potassium tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL040XC(Atorvastatin+Losartan) | Experimental | HL040XC lag time released combination drug |
|
| Losartan + Atorvastatin | Active Comparator | Coadministration group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL040XC | Drug | single dose |
| |
| Losartan + Atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To evaluate its bioequivalency in Cmax and AUC of each test group | 0 ~ 48hr |
| AUC | To evaluate bioequvalency of each group | 0~48HR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore | Maryland | 21201 | United States |
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| Drug |
Single dose |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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