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To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exforge tab. 10/160mg | Active Comparator |
|
|
| Lodivixx tab. 5/160mg | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exforge tab. 10/160mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration) | - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points) | |
| AUC(area under curve) | - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Participants will be followed for the duration of hospital stay, an expected average of 3 days and follow-up period for maximum 6 days from the discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Gook Shin, MD | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 614-735 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18257612 | Background | Plosker GL, Robinson DM. Amlodipine/Valsartan: fixed-dose combination in hypertension. Drugs. 2008;68(3):373-81. doi: 10.2165/00003495-200868030-00008. |
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| ID | Term |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| D017311 | Amlodipine |
| D000068756 | Valsartan |
| C542574 | levamlodipine |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lodivixx tab. 5/160mg |
| Drug |
|
|
| 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 |