To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered orally
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
16
5 days of treatment with 5 mg BI 10773 bid until steady state
5 days of treatment with 10 mg BI 10773 qd until steady state
1276.9.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
AUC (area under the concentration-time curve of the analyte in plasma) - AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for 10 mg BI 10773 QD.
Time frame: up to 168 hours
AUC (area under the concentration-time curve of the analyte in plasma) - AUC0-24,ss (area under the concentration-time curves of the analyte in plasma at steady-state over two dosing intervals) for 5 mg BI 10773 BID after the morning dose on Day 5.
Time frame: up to 168 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.
Time frame: up to 168 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.
Time frame: up to 168 hours
C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose for the BID regimen) of BI 10773.
Time frame: up to 168 hours
C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose for the QD regimen) of BI 10773.
Time frame: up to 168 hours
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773
Time frame: up to 168 hours
Cavg (average concentration of the analyte in plasma at steady state) of BI 10773
Time frame: up to 168 hours
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¿z,ss (terminal half-life of the analyte in plasma at steady state) of BI 10773
Time frame: up to 168 hours
t½,ss (terminal half-life of the analyte in plasma at steady state) of BI 10773
Time frame: up to 168 hours
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.
Time frame: up to 168 hours
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773.
Time frame: up to 168 hours
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773.
Time frame: up to 168 hours
Vz/F,ss (apparent volume of distribution during the terminal phase tau z at steady state following extravascular administration) of BI 10773.
Time frame: up to 168 hours
PTF (percentage peak-trough fluctuation)
Time frame: up to 168 hours