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

LG Chem

Status and phase: Unknown; Phase 1

Conditions: T2DM

Treatments: Drug: Zemiglo 50mg and Forxiga 10mg; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04544319

LG-GLCL002

Details and patient eligibility

About

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

Full description

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

Enrollment: 44 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Arm I

Experimental group

Description:

Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Treatment:

Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Drug: Zemiglo 50mg and Forxiga 10mg

Arm II

Experimental group

Description:

Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg

Treatment:

Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Drug: Zemiglo 50mg and Forxiga 10mg