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To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg |
|
| Arm II | Experimental | Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zemiglo 50mg and Forxiga 10mg | Drug | Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour) |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 0.25hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 0.5hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 0.75hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 1hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 1.5hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 2hour |
| Gemigliptin and dapagliflozin AUClast and Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| Gemigliptin and dapagliflozin AUCinf | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin and dapagliflozin Tmax |
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Inclusion Criteria:
Exclusion Criteria:
Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc
Drug Allergy in aspirin, NSAID, Anti-bacterial drugs
GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...
Chronic urine track infection
Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)
galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
These resluts are appeared when screening
SBP<90mmHg or >150mmHg, DBP <60mmHg or >100mmHg
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| songyi park | Contact | 02-6987-4195 | songyi-park@lgchem.com | |
| clinical LG Chem | Contact | lgclinical@lgchem.com |
| Name | Affiliation | Role |
|---|---|---|
| seunghwan Lee | Seoul National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg | Drug | Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD |
|
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each phase 17 times blood sampling, total 34 times blood sampling
| Day 1 3hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 4hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 6hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 8hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 10hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 12hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 24hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 36hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 48hour |
| Gemigliptin and dapagliflozin AUClast and Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Day 1 72hour |
each phase 17 times blood sampling, total 34 times blood sampling
| Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin and dapagliflozin t1/2 | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin and dapagliflozin CL/F | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin and dapagliflozin V/F | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin metabolite(LC15-0636) AUClast | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin metabolite(LC15-0636) Cmax | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 h), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin metabolite(LC15-0636) AUCinf | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin metabolite(LC15-0636) t1/2 | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |
| Gemigliptin metabolite(LC15-0636) metabolic ratio | each phase 17 times blood sampling, total 34 times blood sampling | Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour |