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

LG Chem44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

T2DM

Interventions

Zemiglo 50mg and Forxiga 10mgDRUG

Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mgDRUG

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Pre-dose (Day1 0 hour)

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Day 1 0.25hour

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Day 1 0.5hour

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Day 1 0.75hour

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Day 1 1hour

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Day 1 1.5hour

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Day 1 2hour

Gemigliptin and dapagliflozin AUClast and Cmax

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: Day 1 3hour

Gemigliptin and dapagliflozin AUClast and Cmax

Central Contacts

songyi park

CONTACT

02-6987-4195 songyi-park@lgchem.com

clinical LG Chem

CONTACT

lgclinical@lgchem.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Gemigliptin and dapagliflozin AUCinf

each phase 17 times blood sampling, total 34 times blood sampling

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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