Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
58
All participants will take 1 tablet of either test drug or 2 tablets of reference drug with fasting conditions.
All participants will take 1 tablet of either test drug or 2 tablest of reference drug with fasting conditions.
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Time to Maximum Concentration(Tmax) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Lag Time(Tlag) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Area Under the Curve to Infinity(AUCinf) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Half-life(t1/2) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: Up to 72 hours
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
Apparent Clearance(CL/F) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: Up to 72 hours
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