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

NCT ID: NCT07333742

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2025-11-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sequence A

Sequence A: Test drug -\> Reference drug

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Sequence B

Sequence B: Reference drug -\> Test drug

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 19-50 years in healthy volunteers

2. 18.0 kg/m^2 ≤ BMI ≤ 29.9 kg/m^2, 50kg ≤weight ≤ 90kg

3. 60≤ FPG≤125 mg/dL

4. Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial.

Exclusion Criteria

1. 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.

2. Subjects with clinically significant abnormal findings during tests (or examinations)

3. Subjects with a history of hypersensitivity or clinically significant hypersensitivity reactions to test drugs or other drugs

4. Subjects judged ineligible by the investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Sang Yu, M.D., Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LG-GMCL001

Identifier Type: -

Identifier Source: org_study_id