The objective was to investigate whether there was a drug-drug interaction between BI 10773 and sitagliptin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in combination compared with BI 10773 or sitagliptin given alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Days 1-8
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Days 1-8
C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose)
Time frame: Days 1-8
λz,ss (terminal half-life of the analyte in plasma)
Time frame: Days 1-8
t½,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: Days 1-8
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Days 1-8
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: Days 1-8
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: Days 1-8
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: Days 1-8
Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ)
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Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
CLR,ss (renal clearance of the analyte at steady state)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
Abnormal findings in physical examination
Time frame: Baseline and within 3-10 days after last study drug administration
Changes from baseline in vital sings (blood pressure, pulse rate)
Time frame: Baseline, day 1 and within 3-10 days after last study drug administration
Changes from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline and within 3-10 days after last study drug administration
Changes from baseline in clinical laboratory tests
Time frame: Baseline, day 1, 5 and within 3-10 days after last study drug administration
Incidence of adverse events
Time frame: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Within 3-10 days after last study drug administration