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

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.

Inclusion Criteria:

1. Healthy Thai male and female subjects between the ages of 18 to 55 years.
2. Body mass index between 18.5 to 30.0 kg/m2.
3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
4. Non-pregnant woman and not currently breast feeding.
5. Female subjects abstain from either hormonal method of contraception or hormone replacement therapy.
6. Male subjects who are willing or able to use effective contraceptive.
7. Have voluntarily given written informed consent by the subject prior to participating in this study.

Exclusion Criteria:

1. History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin.
2. 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.
3. History of evidence of diabetic ketoacidosis.
4. History of evidence of genital infections, urinary tract infections within 14 days prior to check-in.
5. Have a eGFR (CKD-EPI) < 60 mL/min/1.73 m2.
6. History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening.
7. Participated in other clinical trial within 90 days prior to check-in.