Investigate the bioavailability of BI 1356 BS and of metformin after concomitant multiple oral administration of 10 mg BI 1356 BS tablets and 3 x 850 mg metformin in comparison to BI 1356 BS and metformin given alone
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Area under the concentration-time curve (AUC) of the analytes in plasma at different time points
Time frame: up to 240 hours after start of treatment
Maximum concentration (Cmax) of the analytes in plasma at different time points
Time frame: up to 240 hours after start of treatment
Time from last dosing to maximum concentration of the analytes in plasma at steady state (tmax,ss)
Time frame: up to 240 hours after start of treatment
Minimum concentration of the analytes in plasma at steady state (Cmin,ss) over a uniform dosing interval τ
Time frame: up to 240 hours after start of treatment
Terminal rate constant of the analytes in plasma at steady state (λz,ss )
Time frame: up to 240 hours after start of treatment
Terminal half-life of the analytes in plasma at steady state (t1/2,ss )
Time frame: up to 240 hours after start of treatment
Mean residence time of the analytes in the body at steady state after oral administration (MRTpo,ss)
Time frame: up to 240 hours after start of treatment
Apparent clearance of the analytes in the plasma at steady state (CL/F,ss) following extravascular multiple dose administration
Time frame: up to 240 hours after start of treatment
Apparent volume of distribution during the terminal phase λz at steady state (Vz/F,ss) following extravascular administration
Time frame: up to 240 hours after start of treatment
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Measurements of dipeptidylpeptidase 4 (DPP-IV) activity
Time frame: up to 240 hours after start of treatment
Number of patients with adverse events
Time frame: up to 60 days
Number of patients with clinically abnormal changes in laboratory values
Time frame: Baseline, up to 14 days after last drug administration
Number of patients with clinically relevant changes in vital signs
Time frame: Baseline, up to 14 days after last drug administration
feτ,ss (fraction of the dose excreted unchanged in urine at steady state)
Time frame: 0-4 h, 4-8 h, 8-12 h and 12-24 hours after drug administration on days 3, 6, 9
CLR,ss (renal clearance of the analyte in plasma at steady state)
Time frame: 0-4 h, 4-8 h, 8-12 h and 12-24 hours after drug administration on days 3, 6, 9