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This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition |
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| B | Experimental | FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets)) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| AUClast | To evaluate AUClast of gemigliptin and metformin | up to 48 h post-dose |
| Cmax | TO evaluate Cmax of gemigliptin and metformin | up to 48 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin) | up to 48 h post-dose |
| Tmax | To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| up to 48h post-dose |
| t1/2 | To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim) | up to 48 h post-dose |
| Cmax | To evaluate Cmax of LC15-0636(active metabolite of gemigliptim) | up to 48h post-dose |
| AUClast | To evaluate AUClast of LC15-0636(active metabolite of gemigliptim) | up to 48h post-dose |
| D004700 | Endocrine System Diseases |