Study to investigate the bioavailability of BI 1356 with and without co-administration of pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI 1356
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 21 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 21 days
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Time frame: up to 21 days
C24,ss (concentration of the analyte in plasma at steady state after administration of the last dose at the end of the dosing interval)
Time frame: up to 21 days
λz,ss (terminal rate constant in plasma at steady state)
Time frame: up to 21 days
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 21 days
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: up to 21 days
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: up to 21 days
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: up to 21 days
Changes in physical examination (including body weight)
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Time frame: up to 27 days after last administration of study medication
Changes in Vital signs (Blood pressure (BP), Pulse Rate (PR)
Time frame: up to 27 days after last administration of study medication
Changes in 12-lead ECG (electrocardiogram)
Time frame: up to 27 days after last administration of study medication
Changes in clinical laboratory values
Time frame: up to 27 days after last administration of study medication
Number of patients with adverse events
Time frame: up to 27 days after last administration of study medication
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 27 days after last administration of study medication