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The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin | Experimental | Gemigliptin 50mg q.d. during 7 days |
|
| Irbesartan | Experimental | Irbesartan 300mg q.d. during 7 days |
|
| Gemiglitin + Irbesartan | Experimental | Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin | Drug |
| ||
| Irbesartan |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | To evaluate Cmax,ss of Gemigliptin and Irbesartan | up to 72h post-dose |
| AUCτ,ss | To evaluate AUCτ,ss of Gemigliptin and Irbesartan | up to 72h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin,ss | To evaluate Cmin,ss of Gemigliptin and Irbesartan | up to 72h post-dose |
| Tmax,ss | To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin) |
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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 |
|---|---|---|---|
| 25350224 | Derived | Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6. |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
| up to 72h post-dose |
| Cmax,ss | To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin) | up to 72h post-dose |
| AUCτ,ss | To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin) | up to 72h post-dose |
| metabolic ratio | To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin) | up to 72h post-dose |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |