| Outcome Measures: |
Primary: Area under plasma concentration-time curve from zero to infinity (AUCinf), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Maximum observed plasma (peak) drug concentration (Cmax), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Time to reach peak or maximum observed concentration or response following drug administration (tmax), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Apparent total body clearance of drug from plasma after extravascular administration (CL/F), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4|Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F), To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects., Day 1, Day 2, Day 3 and Day 4 | Secondary: Area under plasma concentration-time curve from zero to infinity (AUCinf), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Maximum observed plasma (peak) drug concentration (Cmax), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Time to reach peak or maximum observed concentration or response following drug administration (tmax), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Apparent total body clearance of drug from plasma after extravascular administration (CL/F), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F), To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state., Day 1, Day 2, Day 3 and Day 4|Number of subjects with adverse events (AEs), To assess the safety and tolerability of single doses of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects., From screening (Day -28) to Safety Follow-up (7 to 14 days after the last dosing with the IMP) [up to 66 days]
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