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The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | Tablets, Oral, once daily single dose |
| |
| Metformin IR |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of DWP16001 | Peak Plasma Concetration | 0-72 hours |
| AUClast of DWP16001 | Area under the plasma concentration versus time curve | 0-72 hours |
| Cmax,ss of Metformin | Peak Plasma Concetration at steady-state | 0-144 hours |
| AUCÏ„,ss of Metformin | Area under the plasma concentration versus time curve at Tau, steady-state | 0-144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of DWP 16001, Metformin, DWP16001 Metabolites | Time at Cmax | 0-144 hours |
| AUC of DWP 16001, Metformin, DWP16001 Metabolites | Area under the plasma concentration versus time curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
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| Drug |
Metformin IR 1000mg, Tablets, Oral, BID for 7 days |
|
| DWP16001+Metformin IR | Drug | Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg |
|
| 0-144 hours |
| T1/2 of DWP 16001, Metformin | 0-144 hours |
| CL/F of DWP 16001, Metformin | Apparent total clearance of the drug from plasma after oral administration | 0-144 hours |
| fe of DWP 16001, DWP16001 Metabolites | Fraction of the drug excreted into the urine | 0-72 hours |
| CLR of DWP 16001 | Renal clearance of the drug from plasma | 0-144 hours |