HealthyPhase 1NCT07396844
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers
A Phase 1 study testing Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg in people with Healthy and Fasting, run by LG Chem at 1 site in Thailand.
Trial summary
This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- 11 Jun 2026to 26 Jun 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Thai male and female subjects between the ages of 18 to 55 years.
- Body mass index between 18.5 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Non-pregnant woman and not currently breast feeding.
- Female subjects abstain from either hormonal method of contraception or hormone replacement therapy.
- Male subjects who are willing or able to use effective contraceptive.
- Have voluntarily given written informed consent by the subject prior to participating in this study.
Who cannot join
- History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin.
- History of evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, neurologic, allergic disease, or any significant ongoing chronic medical illness.
- History of evidence of diabetic ketoacidosis.
- History of evidence of genital infections, urinary tract infections within 14 days prior to check-in.
- Have a eGFR (CKD-EPI) < 60 mL/min/1.73 m2.
- History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening.
- Participated in other clinical trial within 90 days prior to check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Randomized, Open-label, Two-way Crossover Food-effect Bioavailbility Study of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg Sustained Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers
This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions.
- Being tested
- Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
- Medical subject headings
- Fasting, Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mgDrug
All participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 : Period 1 (Fasting) - Period 2 (Fed) Receives: Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg |
| Group 2 | Experimental | Group 2 : Period 1 (Fed) - Period 2 (Fasting) Receives: Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 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 PK Parameters: Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
Measured: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Primary PK Parameters: Area Under the Curve to Infinity (AUCinf) of Gemigliptin, Dapagliflozin, and Metformin
Measured: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
Measured: 17 times up to 72 hours after IP administration
Secondary outcomes (2)
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Secondary PK Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin
Measured: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Secondary PK Parameters: Half-life(t1/2) of gemigliptin, dapagliflozin, and metformin
Measured: 17 times up to 72 hours after IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start11 Jun 2026
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Porranee Puranajoti, Principal investigator, International Bio Service Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396844
- Sponsor's protocol ID
- LG-GMCL002
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 10 Sep 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, Two-way Crossover Food-effect Bioavailbility Study of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg Sustained Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07396844
- Acronym / sponsor ID
- LG-GMCL002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 9 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.
This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mgGroup 1 : Period 1 (Fasting) - Period 2 (Fed) |
| Group 2 | Experimental | Drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mgGroup 2 : Period 1 (Fed) - Period 2 (Fasting) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy Thai male and female subjects between the ages of 18 to 55 years.
- Body mass index between 18.5 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Non-pregnant woman and not currently breast feeding.
- Female subjects abstain from either hormonal method of contraception or hormone replacement therapy.
Key exclusion criteria (7 listed)
- History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin.
- History of evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, neurologic, allergic disease, or any significant ongoing chronic medical illness.
- History of evidence of diabetic ketoacidosis.
- History of evidence of genital infections, urinary tract infections within 14 days prior to check-in.
- Have a eGFR (CKD-EPI) < 60 mL/min/1.73 m2.
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 |
|---|---|---|
| Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mgAll participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions. | Drug | Group 1, Group 2 |
Primary outcome
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time frame: 17 times up to 72 hours after IP administration
Primary PK 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: 17 times up to 72 hours after IP administration
Primary PK Parameters: Area Under the Curve to Infinity (AUCinf) of Gemigliptin, Dapagliflozin, and Metformin
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time frame: 17 times up to 72 hours after IP administration
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
2 secondary outcomes
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time frame: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time frame: 17 times up to 72 hours after 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 10 Sep 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.
Porranee Puranajoti principal investigator
International Bio Service Co., Ltd.
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 Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg in people with Healthy and Fasting, run by LG Chem at 1 site in Thailand.
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 7 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 10 Sep 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 Thailand. 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: 17 times up to 72 hours after IP administration). The study lists 3 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 10 Sep 2026.