The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers

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.
• 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.