About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg