Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Clinical Trial to Compare the Pharmacokinetics, Safety and Tolerability of the FDC of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

Conditions
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T2DM

Intervention / Treatment
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* Drug: Zemiglo 50mg and Forxiga 10mg
* Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults who are 19 years   50 years when they are screened weight: 55.0 kg   90.0 kg and BMI: 18.0 kg/m2   30.0 kg/m2 Volunteers who understand the procedures of clinical trial and signed informed consent form Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG Women of chlidbearing potential have negative results in pregnancy test 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 ALT, AST >= 1.5 Upper limit of normal range HbsAg, anti-HCV, HIV Ag&Ab positive MDRD equation: eGFR< 60 mL/min/1.73m2 QTcB> 450 ms Fasting serum glucose < 70mg/dL or >110mg/dL HbA1c>6.5% SBP<90mmHg or >150mmHg, DBP <60mmHg or >100mmHg

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg | Drug: Zemiglo 50mg and Forxiga 10mg<br>* Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD<br>* Other names: zemiglo and Forxiga;Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg<br>* Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD<br>* Other names: zemiglo and Forxiga;|
| Experimental: Arm II<br>Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg | Drug: Zemiglo 50mg and Forxiga 10mg<br>* Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD<br>* Other names: zemiglo and Forxiga;Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg<br>* Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD<br>* Other names: zemiglo and Forxiga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |