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

T2DM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04544319
• Other study ID #: LG-GLCL002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 2020
• Est. completion date: July 2021

Study information

• Verified date: September 2020
• Source: LG Chem
• Contact: songyi park
• Phone: 02-6987-4195
• Email: songyi-park[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: July 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• T2DM

Intervention

Drug:
• Zemiglo 50mg and Forxiga 10mg
Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD
• Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Pre-dose (Day1 0 hour)
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 0.25hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 0.5hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 0.75hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 1hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 1.5hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 2hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 3hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 4hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 6hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 8hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 10hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 12hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 24hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 36hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 48hour
Primary	Gemigliptin and dapagliflozin AUClast and Cmax	each phase 17 times blood sampling, total 34 times blood sampling	Day 1 72hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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