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 range18 Years – 55 Years
SexALL
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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.
Exclusion criteria
✕. 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.
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