A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal

NCT07333742 | Completed Phase 1

• 1 other identifier: LG-GMCL001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers

Conditions

Fed Conditions; Healthy Volunteer

Keywords

Bioequivalence study; Fed condition

Outcome Measures

Primary Outcomes (2)

• The plasma concentration of gemigliptin, dapagliflozin, and metformin

  Primary Parameters: Area under the plasma concentration versus time curve (AUClast) of gemigliptin, dapagliflozin, and metformin

  - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

• The plasma concentration of gemigliptin, dapagliflozin, and metformin

  Primary Paramenters: Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, and metformin

  - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

Secondary Outcomes (6)

• The plasma concentration of gemigliptin, dapagliflozin and metformin

  Period 1: 16 times up to 72 hours from IP administration Period 2: 16 times up to 72 hours from IP administration

• The plasma concentration of gemigliptin, dapagliflozin and metformin

  - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

• The plasma concentration of gemigliptin, dapagliflozin and metformin

  - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

• The plasma concentration of gemigliptin, dapagliflozin and metformin

  - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

• The plasma concentration of gemigliptin, dapagliflozin and metformin

  - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration

Other Outcomes (5)

• Assessment - Safety (Adverse events)

  up to day 18 (post study visit)

• Assessment - Safety (Physical examination)

  3 times until 72 hours from IP administration

• Assessment - Safety (Vital sign)

  7 times until 72 hours from IP administration

Study Arms (2)

Sequence A

EXPERIMENTAL

Sequence A: Test drug -\> Reference drug

Drug: Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; Drug: Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg

Sequence B

EXPERIMENTAL

Sequence B: Reference drug -\> Test drug

Drug: Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; Drug: Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg

Interventions

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

All participants take 1 tablet of either test drug or reference drug after meal.

Sequence A; Sequence B

Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg DRUG

All participants take 1 tablet of either test drug or reference drug after meal.

Sequence A; Sequence B

Eligibility Criteria

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

You may qualify if:

• Age 19-50 years in healthy volunteers
• kg/m\^2 ≤ BMI ≤ 29.9 kg/m\^2, 50kg ≤weight ≤ 90kg
• ≤ FPG≤125 mg/dL
• Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial.

You may not qualify if:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system.
• Subjects with clinically significant abnormal findings during tests (or examinations)
• Subjects with a history of hypersensitivity or clinically significant hypersensitivity reactions to test drugs or other drugs
• Subjects judged ineligible by the investigator

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation; LC15-0444; dapagliflozin; Metformin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kyung-Sang Yu, M.D., Professor

  Seoul 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: November 24, 2025
• First Posted: January 12, 2026
• Study Start: September 29, 2025
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)