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The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin and Glimepiride | Experimental | Multiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride |
|
| Glimepiride | Experimental | Single administration of glimepiride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin and Glimepiride | Drug | Gemigliptin 50mg (qd) on Day1~Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | To evaluate AUCĪ,ss of gemigliptin and AUClast of glimepiride | up to 24h post-dose |
| Cmax | To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride | up to 24h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1 | up to 24h post-dose |
| t1/2β | To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
| C057619 | glimepiride |
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| Glimepiride | Drug | Glimepiride 4mg (qd) on Day1 |
|
| up to 24h post-dose |
| AUC | To evaluate AUCĪ,ss of LC15-0636 and AUClast of M1 | up to 24h post-dose |
| Cmax | To evaluate Cmax,ss of LC15-0636 and Cmax of M1 | up to 24h post-dose |