Healthy VolunteersPhase 1NCT07399470
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.
A Phase 1 study testing Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg and Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg in people with Healthy Volunteers and Fasting Conditions, 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 fasting 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
- Healthy Volunteers, Fasting Conditions
- What is being tested?
- Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg and Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (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
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jan 2026to 6 Feb 2026
- 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
- Healthy adults between 19 and 50 years of age
- People with a body weight within a healthy range
- People who do not have serious medical conditions and have been generally healthy in recent years
- People whose screening tests (blood tests, urine tests, vital signs, ECG, etc.) show no significant abnormalities
- Women of childbearing potential must not be pregnant at screening
- Participants must agree to use reliable contraception or abstain from sexual activity during the study and for a short period after the last dose
- People who fully understand the study, agree to follow study requirements, and provide written informed consent
Who cannot join
- People with a history of significant diseases, such as heart, liver, kidney, lung, neurological, psychiatric, immune, or cancer-related conditions
- People with digestive diseases or surgeries that may affect how medicines are absorbed
- People with abnormal screening laboratory results, especially related to liver or kidney function
- People who drink large amounts of alcohol, use drugs, or smoke heavily
- People who have recently taken certain medications, herbal products, or dietary supplements that could interfere with the study
- People who have recently participated in another clinical trial, donated blood, or received a blood transfusion
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- Pregnant or breastfeeding women
- People with unstable or serious health conditions that could increase risk or affect study results
- Anyone who, in the opinion of the study doctor, is not suitable to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: Randomized, Open-label, Single-dose, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of a Triple Fixed-dose Combination Tablet (Gemigliptin/Dapagliflozin/Metformin) 50/10/1000 mg and Co-administered Zemiglo (Gemigliptin) 50 mg and Xigduo XR (Dapagliflozin/Metformin) 10/1000 mg in Healthy Adult Subjects Under Fasting Conditions
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
- Conditions
- Healthy Volunteers, Fasting Conditions
- Being tested
- Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg
- Keywords
- Fasting conditions, Healthy Volunteers, Bioequivalence Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mgDrug
All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.
Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mgDrug
All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | test drug > reference drug Receives: Drug: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; Drug: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg |
| Sequence 2 | Experimental | reference drug > test drug Receives: Drug: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg; Drug: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (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
Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
Measured: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
Measured: Up to 72 hours
Secondary outcomes (5)
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time to Maximum Concentration(Tmax) of Gemigliptin, Dapagliflozin, and Metformin
Measured: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Lag Time(Tlag) of Gemigliptin, Dapagliflozin, and Metformin
Measured: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Area Under the Curve to Infinity(AUCinf) of Gemigliptin, Dapagliflozin, and Metformin
Measured: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Half-life(t1/2) of Gemigliptin, Dapagliflozin, and Metformin
Measured: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Apparent Clearance(CL/F) of Gemigliptin, Dapagliflozin, and Metformin
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start9 Jan 2026
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seol Ju Moon, M.D., Professor, Principal investigator, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399470
- Sponsor's protocol ID
- LG-GMCL003
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2026
- Last updated
- 24 Jul 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Single-dose, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of a Triple Fixed-dose Combination Tablet (Gemigliptin/Dapagliflozin/Metformin) 50/10/1000 mg and Co-administered Zemiglo (Gemigliptin) 50 mg and Xigduo XR (Dapagliflozin/Metformin) 10/1000 mg in Healthy Adult Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT07399470
- Acronym / sponsor ID
- LG-GMCL003
- Conditions
- Healthy Volunteers, Fasting Conditions
- Keywords
- Fasting conditions, Healthy Volunteers, Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 10 Feb 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 fasting 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 1 | Experimental | Drug: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Drug: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mgtest drug > reference drug |
| Sequence 2 | Experimental | Drug: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Drug: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mgreference drug > test drug |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults between 19 and 50 years of age
- People with a body weight within a healthy range
- People who do not have serious medical conditions and have been generally healthy in recent years
- People whose screening tests (blood tests, urine tests, vital signs, ECG, etc.) show no significant abnormalities
- Women of childbearing potential must not be pregnant at screening
Key exclusion criteria (9 listed)
- People with a history of significant diseases, such as heart, liver, kidney, lung, neurological, psychiatric, immune, or cancer-related conditions
- People with digestive diseases or surgeries that may affect how medicines are absorbed
- People with abnormal screening laboratory results, especially related to liver or kidney function
- People who drink large amounts of alcohol, use drugs, or smoke heavily
- People who have recently taken certain medications, herbal products, or dietary supplements that could interfere with the study
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 of gemigliptin/dapagliflozin/metformin 50/10/1000 mgAll participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions. | Drug | Sequence 1, Sequence 2 |
| Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mgAll participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions. | Drug | Sequence 1, Sequence 2 |
Primary outcome
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Time frame: Up to 72 hours
Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Time frame: Up to 72 hours
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
5 secondary outcomes
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Time frame: Up to 72 hours
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 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Seol Ju Moon, M.D., Professor principal investigator
Jeonbuk 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 of gemigliptin/dapagliflozin/metformin 50/10/1000 mg and Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg in people with Healthy Volunteers and Fasting Conditions, 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 7 inclusion and 9 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 24 Jul 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: Up to 72 hours). 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 24 Jul 2026.