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This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D → M → D+M | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid |
|
| D → D+M → M | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid |
|
| M → D → D+M | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid |
|
| M → D+M → D | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid |
|
| D+M → M → D | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid |
|
| D+M → D → M |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-1229 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,ss of DA-1229 and metformin | up to 168h | |
| Cmax,ss of DA-1229 and metformin | up to 168h |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Seoul National University Hospital | Seoul | 110-744 | South Korea |
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D : DA-1229 5mg qd, M : metformin 1000mg bid |
|
| metformin |
| Drug |
|
| DA-1229 + metformin | Drug |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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