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

January 2, 2026 updated by: LG Chem

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The plasma concentration of gemigliptin, dapagliflozin, and metformin
Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
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
Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The plasma concentration of gemigliptin, dapagliflozin and metformin
Time Frame: Period 1: 16 times up to 72 hours from IP administration Period 2: 16 times up to 72 hours from IP administration
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
Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
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
Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
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
Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
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
Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
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
Time Frame: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment - Safety (Adverse events)
Time Frame: up to day 18 (post study visit)
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)
Time Frame: 3 times until 72 hours from IP administration
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)
Time Frame: 7 times until 72 hours from IP administration
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)
Time Frame: 4 times until post-study visit
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)
Time Frame: 4 times until post-study visit
Hematology, Blood Chemistry, Urinalysis
4 times until post-study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LG Chem

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kyung-Sang Yu, M.D., Professor, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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