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This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC) |
|
| Sequence B | Experimental | Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SID1903 (FDC) | Drug | Single oral administration of SID1903 (FDC) after an overnight fast |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | up to 72 hours | |
| Cmax | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | up to 72 hours | |
| AUCinf | up to 72 hours | |
| t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dapagliflozin and Sitagliptin | Drug | Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast |
|
| up to 72 hours |
| CL/F | up to 72 hours |
| Vd/F | up to 72 hours |
| λz | up to 72 hours |
| MRT | up to 72 hours |
| D011719 |
| Pyrazines |