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A study demonstrates the bioequivalence of DA-1229_01(A) at Fed State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test drug, Reference drug group | Experimental | Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. |
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| Reference drug,Test drug group | Active Comparator | Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-1229_01(A), Sugamet SR Tab 5/1000mg® | Drug | Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve(AUCt) | AUCt of metformin | Hour -1 ~ Hour 24 |
| Maximum plasmaconcentration of drug in plasma(Cmax) | Cmax of metformin | Hour -1 ~ Hour 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf) | AUCinf of metformin | Hour -1 ~ Hour 24 |
| AUCt/AUCinf | AUCt/AUCinf of metformin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung Dae Kwon, M.D., Ph.D. | Metro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metro Hospital | Anyang-si | Gyeonggi-do | 14096 | South Korea |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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|
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| Sugamet SR Tab 5/1000mg®, DA-1229_01(A) | Drug | Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. |
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| Hour -1 ~ Hour 24 |
| Time to reach the maximum plasma concentration(Tmax) | Tmax of metformin | Hour -1 ~ Hour 24 |
| Terminal elimination rate constant(ramda z) | ramda z of metformin | Hour -1 ~ Hour 24 |
| Terminal elimination half-life(t1/2) | t1/2 of metformin | Hour -1 ~ Hour 24 |