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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
All participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.
Siriraj Hospital
Nakhon Pathom, Thailand
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Primary PK Parameters: Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Primary PK Parameters: Area Under the Curve to Infinity (AUCinf) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
Time frame: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Secondary PK Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin
Time frame: 17 times up to 72 hours after IP administration
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Secondary PK Parameters: Half-life(t1/2) of gemigliptin, dapagliflozin, and metformin
Time frame: 17 times up to 72 hours after IP administration
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