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The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LC15-0444 | Experimental | LC15-0444 50mg qd |
|
| Metformin | Experimental | Metformin 1000mg bid |
|
| LC15-0444+Metformin | Experimental | LC15-0444 50mg qd +Metformin 1000mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC15-0444 | Drug | LC15-0444 50mg qd (8 days once daily) |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss | To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444 | up to 171h30m |
| Cmax,ss | To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444 | up to 171h 30m |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | to measure Safety and tolerability of the investigational products | up to 171h30m |
| AUECÏ„,ss | Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure DPP4 activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, M.D,Ph.D | Seoul national univ. hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24627290 | Derived | Shin D, Cho YM, Lee S, Lim KS, Kim JA, Ahn JY, Cho JY, Lee H, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014 Jun;34(6):383-93. doi: 10.1007/s40261-014-0184-3. |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
Metformin 1000 mg bid (8 days twice daily) |
|
| LC15-0444+Metformin | Drug | LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily) |
|
| up to 171h30m |
| AUEC | Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure Active/total GLP-1, glucose, insulin, c-peptide, glucagon. | up to 171h30m |