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.

NCT07399470 | Active Not Recruiting Phase 1

• 1 other identifier: LG-GMCL003
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers; Fasting Conditions

Keywords

Fasting conditions; Healthy Volunteers; Bioequivalence Study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.

  Up to 72 hours

• The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

  Up to 72 hours

• The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

  Up to 72 hours

• The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

  Up to 72 hours

• The plasma concentration of Gemigliptin, Dapagliflozin and Metformin

  Up to 72 hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

test drug \> reference drug

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

Sequence 2

EXPERIMENTAL

reference drug \> test drug

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

Interventions

Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg DRUG

All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.

Sequence 1; Sequence 2

Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg DRUG

All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation; dapagliflozin; Metformin

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Seol Ju Moon, M.D., Professor

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 10, 2026
• Study Start: January 9, 2026
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)