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Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | test drug > reference drug |
|
| Sequence 2 | Experimental | reference drug > test drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg | Drug | All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin | Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin | Up to 72 hours |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin | Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. | Time to Maximum Concentration(Tmax) of Gemigliptin, Dapagliflozin, and Metformin | Up to 72 hours |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seol Ju Moon, M.D., Professor | Jeonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg | Drug | All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions. |
|
Lag Time(Tlag) of Gemigliptin, Dapagliflozin, and Metformin
| Up to 72 hours |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin | Area Under the Curve to Infinity(AUCinf) of Gemigliptin, Dapagliflozin, and Metformin | Up to 72 hours |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin | Half-life(t1/2) of Gemigliptin, Dapagliflozin, and Metformin | Up to 72 hours |
| The plasma concentration of Gemigliptin, Dapagliflozin and Metformin | Apparent Clearance(CL/F) of Gemigliptin, Dapagliflozin, and Metformin | Up to 72 hours |
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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