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This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G+M | Experimental | Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg |
|
| C | Experimental | Combination of gemigliptin50mg/metformin HCl extended release 500mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemigliptin and metformin HCl extended release | Drug | Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast, Cmax | To evaluate AUClast and Cmax of gemigliptin and metformin | up to 48h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf, Tmax, t1/2, CL/F, metabolic ratio | To evaluate AUCinf, Tmax, t1/2 and CL/F of gemigliptin and metformin, To evaluate AUClast, Cmax and metabolic ratio of gemigliptin metabolite LC15-0636 | up to 48h post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, M.D,Ph.D | Seoul national univ. hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| gemigliptin/metformin HCl extended release | Drug | Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day. |
|
| ID | Term |
|---|---|
| C534891 | LC15-0444 |
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