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A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G+M | Active Comparator | Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets |
|
| C | Experimental | Combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets |
|
| 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 * 2 tablets, 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 |
|---|---|---|
| Tmax of Gemigliptin, Metformin | up to 48h post-dose | |
| AUCinf of Gemigliptin, Metformin | up to 48h post-dose | |
| t1/2 of Gemigliptin, Metformin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University College of Medicine | Seoul | South Korea |
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| gemigliptin/metformin HCl extended release | Drug | Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets, for 1day |
|
| up to 48h post-dose |
| CL/F of Gemigliptin, Metformin | up to 48h post-dose |
| Vd/F of Gemigliptin, Metformin | up to 48h post-dose |
| AUC0-48h of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| Cmax of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| Tmax of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| AUCinf of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| t1/2 of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| CL/F of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| Vd/F of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| ID | Term |
|---|---|
| C534891 | LC15-0444 |
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