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To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab 160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and Crestor® (Rosuvastatin) 20 mg in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed-dose combination VR 160/20 mg-1 | Experimental | Fixed-dose combination VR 160/20 mg-1 is administered by mouth at Day 1, 8 and 15. |
|
| Fixed-dose combination VR 160/20 mg-2 | Experimental | Fixed-dose combination VR 160/20 mg-2 is administered by mouth at Day 1, 8 and 15. |
|
| Valsartan 160mg placebo + Rosuvastatin 20mg | Experimental | Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered by mouth at Day 1, 8 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of valsartan and rosuvastatin | 0h(pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 12h, 24h, 48h for each period (total 16 times) | |
| AUC last of valsartan and rosuvastatin | 0h(pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 12h, 24h, 48h for each period (total 16 times) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | The severity of adverse events and their relationship with the investigational products are schematized by treatment group. Descriptive statistics are calculated for the frequency, percentage, 12-lead ECG and clinical laboratory tests results of the subjects who have adverse events and the results of each item are reviewed. | -28~-2d, 1d, 2d, 3d, 8d, 9d, 10d, 15d, 16d, 17d, 21 ± 2d |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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|
| Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1) | Drug |
|
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| Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1) | Drug |
|
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| Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ) | Drug |
|
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| Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R ) | Drug |
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| Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2) | Drug |
|
|
| 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 |
|---|---|
| D000068756 | Valsartan |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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