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

A Randomized, Open Label, Single Oral Dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg and Coadministration of Gemigliptin 50 mg and Dapagliflozin/Metformin 10/1000 mg in Healthy Adults in Fed Condition

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Fed Conditions
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

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 A; Sequence A: Test drug -> Reference drug	Drug: 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.; 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.
Experimental: Sequence B; Sequence B: Reference drug -> Test drug	Drug: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The plasma concentration of gemigliptin, dapagliflozin and metformin	Secondary Parameters: Time to Maximum(Tmax) 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	Secondary Parameters: Lag Time(Tlag) 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	Secondary Parameters: Area Under the Curve to Infinity(AUCinf) 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	Secondary Parameters: Half-life(t1/2) 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	Secondary Parameters: Apparent Clearance(CL/F) 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	Secondary Parameters: Apparent Volume of Distribution(Vz/F) 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment - Safety (Adverse events)	A list of all adverse events for each treatment group and for all participants with seriousness, severity, relationship with investigational product. A number of participant with adverse event.	up to day 18 (post study visit)
Assessment - Safety (Physical examination)	Any finding in general condition, nutritional status and other category by medical interview	3 times until 72 hours from IP administration
Assessment - Safety (Vital sign)	Systolic Blood Pressure(mmHg), Diastolic Blood Pressure(mmHg), Pulse Rate(beats/min), Temperature(℃)	7 times until 72 hours from IP administration
Assessment - Safety (12-lead ECG results)	Ventricular rate(beats/min), PR interval(msec), QRS(msec), QT(msec), QTcB(msec)	4 times until post-study visit
Assessment - Safety (Clinical laboratory test results)	Hematology, Blood Chemistry, Urinalysis	4 times until post-study visit

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Kyung-Sang Yu, M.D., Professor, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Actual): November 27, 2025
• Study Completion (Actual): November 27, 2025

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Bioequivalence study; Fed condition
• Additional Relevant MeSH Terms: Organic Chemicals; Investigative Techniques; Biguanides; Guanidines; Amidines; Evaluation Studies as Topic; Drug Development; Metformin; dapagliflozin; Drug Evaluation; LC15-0444
• Other Study ID Numbers: LG-GMCL001

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