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

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

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

Study Overview

• Status: Unknown
• Conditions: T2DM
• Intervention / Treatment: Drug: Zemiglo 50mg and Forxiga 10mg; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg	Drug: Zemiglo 50mg and Forxiga 10mg; Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD; Other Names: zemiglo and Forxiga; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg; Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD; Other Names: zemiglo and Forxiga
Experimental: Arm II; Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg	Drug: Zemiglo 50mg and Forxiga 10mg; Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD; Other Names: zemiglo and Forxiga; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg; Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD; Other Names: zemiglo and Forxiga

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: LG-GLCL002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No