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

Phase 1

• Conditions: T2DM
• Interventions: Drug: Zemiglo 50mg and Forxiga 10mg; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

• Registration Number: NCT04544319
• Lead Sponsor: LG Chem

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2020-07-29
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-11
• Study Start: 2020-10
• Primary Completion: 2021-03
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm I	Zemiglo 50mg and Forxiga 10mg	Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Arm I	Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg	Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Arm II	Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg	Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg
Arm II	Zemiglo 50mg and Forxiga 10mg	Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg

Primary Outcome Measures

Name	Time	Method
Gemigliptin and dapagliflozin AUClast and Cmax	Day 1 72hour	each phase 17 times blood sampling, total 34 times blood sampling

Secondary Outcome Measures

Name	Time	Method
Gemigliptin and dapagliflozin CL/F	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) AUClast	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) t1/2	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUCinf	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin V/F	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin Tmax	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) metabolic ratio	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin t1/2	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) Cmax	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) AUCinf	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	each phase 17 times blood sampling, total 34 times blood sampling