A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.

Randomized, Open-label, Single-dose, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of a Triple Fixed-dose Combination Tablet (Gemigliptin/Dapagliflozin/Metformin) 50/10/1000 mg and Co-administered Zemiglo (Gemigliptin) 50 mg and Xigduo XR (Dapagliflozin/Metformin) 10/1000 mg in Healthy Adult Subjects Under Fasting Conditions

Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers; Fasting Conditions
• Intervention / Treatment: Drug: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; Drug: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, South Korea, 54907
      • Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults between 19 and 50 years of age
• People with a body weight within a healthy range
• People who do not have serious medical conditions and have been generally healthy in recent years
• People whose screening tests (blood tests, urine tests, vital signs, ECG, etc.) show no significant abnormalities
• Women of childbearing potential must not be pregnant at screening
• Participants must agree to use reliable contraception or abstain from sexual activity during the study and for a short period after the last dose
• People who fully understand the study, agree to follow study requirements, and provide written informed consent

Exclusion Criteria:

• People with a history of significant diseases, such as heart, liver, kidney, lung, neurological, psychiatric, immune, or cancer-related conditions
• People with digestive diseases or surgeries that may affect how medicines are absorbed
• People with abnormal screening laboratory results, especially related to liver or kidney function
• People who drink large amounts of alcohol, use drugs, or smoke heavily
• People who have recently taken certain medications, herbal products, or dietary supplements that could interfere with the study
• People who have recently participated in another clinical trial, donated blood, or received a blood transfusion
• Pregnant or breastfeeding women
• People with unstable or serious health conditions that could increase risk or affect study results
• Anyone who, in the opinion of the study doctor, is not suitable to participate

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: Sequence 1; test drug > reference drug	Drug: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.; Drug: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg; All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.
Experimental: Sequence 2; reference drug > test drug	Drug: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.; Drug: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg; All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin	Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin	Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin	Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.	Time to Maximum Concentration(Tmax) of Gemigliptin, Dapagliflozin, and Metformin	Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin	Lag Time(Tlag) of Gemigliptin, Dapagliflozin, and Metformin	Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin	Area Under the Curve to Infinity(AUCinf) of Gemigliptin, Dapagliflozin, and Metformin	Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin	Half-life(t1/2) of Gemigliptin, Dapagliflozin, and Metformin	Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin	Apparent Clearance(CL/F) of Gemigliptin, Dapagliflozin, and Metformin	Up to 72 hours

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Seol Ju Moon, M.D., Professor, Jeonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Bioequivalence Study; Fasting conditions
• Additional Relevant MeSH Terms: Organic Chemicals; Investigative Techniques; Biguanides; Guanidines; Amidines; Evaluation Studies as Topic; Drug Development; Metformin; dapagliflozin; Drug Evaluation
• Other Study ID Numbers: LG-GMCL003

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