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
Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
After 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.
After 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
Time frame: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Pharmacokinetic characterization
Time frame: 0 hour ~ 48 hour after drug administration
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