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Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemigliptin only | Experimental | Multiple administrations of gemigliptin |
|
| rosuvastatin only | Experimental | Multiple administrations of rosuvastatin |
|
| gemigliptin and rosuvastatin | Experimental | Multiple administrations of gemigliptin and rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemigliptin only | Drug | gemigliptin 50mg qd on day 1~7 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | to evaluate Cmax of gemigliptin and rosuvastatin at steady state | up to 72 hour post dose |
| AUC | to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state | up to 72 hour post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin | up to 72 hour post dose |
| Cmin | to evaluate Cmin of gemigliptin and rosuvastatin at steady state |
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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 |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| rosuvastatin only |
| Drug |
rosuvastatin 20mg qd on day 1~7 |
|
| gemigliptin and rosuvastatin | Drug | gemigliptin 50mg, rosuvastatin 20mg qd on day 1~7 |
|
| upto 72 hour post dose |
| t1/2β | to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin | upto 72 hour post dose |
| Cmax | to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state | upto 72 hour post dose |
| AUC | to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state | upto 72 hour post dose |
| metabolic ratio | to evaluate metabolic ratio of gemiglipin and rosuvastatin | upto 72 hour post dose |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |