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

• Status: Not yet recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Chem
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

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