Fed ConditionsPhase 1NCT07333742
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 Phase 1 study testing Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg and Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg in people with Fed Conditions and Healthy Volunteer, run by LG Chem at 1 site in South Korea.
Trial summary
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fed Conditions, Healthy Volunteer
- What is being tested?
- Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg and Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2025to 27 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19-50 years in healthy volunteers
- 18.0 kg/m^2 ≤ BMI ≤ 29.9 kg/m^2, 50kg ≤weight ≤ 90kg
- 60≤ 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Fed Conditions, Healthy Volunteer
- Being tested
- Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
- Keywords
- Bioequivalence study, Fed condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mgDrug
All participants take 1 tablet of either test drug or reference drug after meal.
Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mgDrug
All participants take 1 tablet of either test drug or reference drug after meal.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Sequence A: Test drug -> Reference drug Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma concentration of gemigliptin, dapagliflozin, and metformin
Primary Parameters: Area under the plasma concentration versus time curve (AUClast) of gemigliptin, dapagliflozin, and metformin
Measured: - 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
Measured: - 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
Secondary Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin
Measured: 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
Measured: - 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
Measured: - 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
Measured: - 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
Measured: - 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
Measured: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start29 Sep 2025
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fed ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333742
- Sponsor's protocol ID
- LG-GMCL001
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07333742
- Acronym / sponsor ID
- LG-GMCL001
- Conditions
- Fed Conditions, Healthy Volunteer
- Keywords
- Bioequivalence study, Fed condition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | 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 mgSequence A: Test drug -> Reference drug |
| Sequence B | Experimental | 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 mgSequence B: Reference drug -> Test drug |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 19-50 years in healthy volunteers
- 18.0 kg/m^2 ≤ BMI ≤ 29.9 kg/m^2, 50kg ≤weight ≤ 90kg
- 60≤ 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mgAll participants take 1 tablet of either test drug or reference drug after meal. | Drug | Sequence A, Sequence B |
| Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mgAll participants take 1 tablet of either test drug or reference drug after meal. | Drug | Sequence A, Sequence B |
Primary outcome
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu, M.D., Professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg and Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg in people with Fed Conditions and Healthy Volunteer, run by LG Chem at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.