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

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

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

Inclusion Criteria:

1. Healthy adults who are 19 years ~ 50 years when they are screened
2. weight: 55.0 kg ~ 90.0 kg and BMI: 18.0 kg/m2 ~ 30.0 kg/m2
3. Volunteers who understand the procedures of clinical trial and signed informed consent form
4. Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG
5. Women of chlidbearing potential have negative results in pregnancy test

Exclusion Criteria:

1. Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc

2. Drug Allergy in aspirin, NSAID, Anti-bacterial drugs

3. GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...

4. Chronic urine track infection

5. Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)

6. galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

7. 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%

8. SBP<90mmHg or >150mmHg, DBP <60mmHg or >100mmHg