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This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered 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 1000mg |
|
| C | Experimental | Combination of gemigliptin50mg/metformin HCl extended release 1000mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemigliptin and metformin HCl extended release | Drug | Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | To evaluate AUClast of gemigliptin and metformin | up to 48h post-dose |
| Cmax | To evaluate Cmax of gemigliptin and metformin | up to 48h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUEC | This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity. | up to 48h post-dose |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25678778 | Derived | Park SI, Lee H, Oh J, Lim KS, Jang IJ, Kim JA, Jung JH, Yu KS. A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects. Drug Des Devel Ther. 2015 Feb 4;9:729-36. doi: 10.2147/DDDT.S75980. eCollection 2015. |
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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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