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The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 20mg and Metformin XR 1000mg with coadministration of the two separate drugs in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group A | Experimental |
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| Sequence Group B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDC(MP-513 20mg/Metformin XR 1000mg) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC of MP-513 and metformin | PK assessment | - 0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose(a total of 36 times, with 18 times per period) |
| Cmax of MP-513 and metformin | PK assessment | - 0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose(a total of 36 times, with 18 times per period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical trials center of Chungnam National University Hospital | Daejeon | Jung-gu | 301-721 | South Korea |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| MP-513 20mg |
| Drug |
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| Metformin XR 1000mg | Drug |
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