The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metfor… (NCT07396844) | Clinical Trial Compass
Not Yet RecruitingPhase 1
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers
Thailand28 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Timeframe: 17 times up to 72 hours after IP administration
2
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Timeframe: 17 times up to 72 hours after IP administration
3
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Timeframe: 17 times up to 72 hours after IP administration
. 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.