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This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Part 1) DA-1229_01 → E+M | Experimental | DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg |
|
| (Part 1) E+M → DA-1229_01 | Experimental | DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg |
|
| (Part 2) DA-1229_01 fast → fed | Experimental | DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet |
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| DA-1229_01 fed → fast | Experimental | DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-1229_01 | Drug | complex single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve(AUC)last of Evogliptin and Metformin | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | |
| Maximum of concentration (Cmax) of Evogliptin and Metformin | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration(Tmax) of Evogliptin and Metformin | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | |
| Terminal half-life(t1/2) of Evogliptin and Metformin | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, Ph.d., M.B.A | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Seoul National University Hospital | Seoul | South Korea |
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| E+M | Drug | co-administration of 2 drugs |
|
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| DA-1229_01 fast | Drug |
|
| DA-1229_01 fed | Drug |
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| Apparent Clearance(CL/F) of Evogliptin and Metformin | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |
| Area Under Curve(AUC)inf of Evogliptin and Metformin | AUCinf = AUC last + Clast/λz | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |
| Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial) | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
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