This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
Healthy adults aged 19 to 54 years
BMI measurement result is 18.0 kg/m2 to 30 kg/m2
Written informed consent
Other inclusion criteria, as defined in the protocol
who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period
Other exclusive criteria, as defined in the protocol
Crossover
CKD-383(Fed)
DrugAfter maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.
CKD-383(Fasted)
DrugAfter maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Pharmacokinetic characterization
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Pharmacokinetic characterization
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