The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity)
Time frame: up to 48 hours after drug administration
AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h)
Time frame: up to 48 hours after drug administration
AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h)
Time frame: up to 48 hours after drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
tmax (time from dosing to maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
λz (terminal rate constant in plasma after single dose
Time frame: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma after single dose)
Time frame: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after single dose)
Time frame: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose)
Time frame: up to 48 hours after drug administration
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Vz/F (apparent volume of distribution during the terminal phase λz after single dose following extravascular administration)
Time frame: up to 48 hours after drug administration
AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2)
Time frame: up to 24 hours after drug administration
Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2)
Time frame: up to 24 hours after drug administration
fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2)
Time frame: up to 24 hours after drug administration
CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2)
Time frame: up to 24 hours after drug administration
Amount of glucose excreted in urine
Time frame: up to 24 hours after drug administration
Number of patients with adverse events
Time frame: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in laboratory tests
Time frame: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in Electrocardiogram (ECG)
Time frame: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in vital signs
Time frame: up to 48 hours after last administration of study drug
Assessment of global tolerability by investigator on a 4-point scale
Time frame: 48 hours after last administration of study drug