The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs
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: Before each dosing, up to 10 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Before each dosing, up to 10 days
C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose)
Time frame: Before each dosing, up to 10 days
λz (terminal elimination rate constant of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
t½ (terminal half-life of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
tmax (time from last dosing to maximum measured concentration of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
MRTpo (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: Before each dosing, up to 10 days
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Before each dosing, up to 10 days
Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration)
Time frame: Before each dosing, up to 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aet1-t2 (amount of analyte eliminated in urine over the time interval t1 to t2 )
Time frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
fet1-t2 (fraction of dose excreted unchanged in urine over the time interval t1 to t2)
Time frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
CLR (renal clearance of the analyte in plasma afer extravascular administration)
Time frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
Cmax (maximum concentration of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration)
Time frame: Before each dosing, up to 10 days
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration within the first dosing interval)
Time frame: Before each dosing, up to 10 days
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Before each dosing, up to 10 days
Metabolite to parent ratio
Time frame: Before each dosing, up to 10 days
Number of patients with abnormal findings in physical examination
Time frame: up to 30 days after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 30 days after drug administration
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 30 days after drug administration
Number of patients with clinically significant changes in vital signs
Time frame: up to 30 days after drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 10 days
Number of patients with adverse events
Time frame: up to 51 days