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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 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 sustained 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 |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30288156 | Derived | Cho YS, Lee SH, Lim HS, Bae KS. Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects. J Korean Med Sci. 2018 Sep 5;33(41):e258. doi: 10.3346/jkms.2018.33.e258. eCollection 2018 Oct 8. |
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| gemigliptin/metformin HCl sustained release | Drug | Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day. |
|
| ID | Term |
|---|---|
| C534891 | LC15-0444 |
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