Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)

简要总结

主要结局

次要结局

• λz (terminal elimination rate constant of the analyte in plasma)(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)(Before each dosing, up to 10 days)
• Metabolite to parent ratio(Before each dosing, up to 10 days)
• Number of patients with abnormal changes in laboratory parameters(up to 30 days after drug administration)
• t½ (terminal half-life of the analyte in plasma)(Before each dosing, up to 10 days)
• C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose)(Before each dosing, up to 10 days)
• Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration)(Before each dosing, up to 10 days)
• fet1-t2 (fraction of dose excreted unchanged in urine over the time interval t1 to t2)(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))
• CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(Before each dosing, up to 10 days)
• Aet1-t2 (amount of analyte eliminated in urine over the time interval t1 to t2 )(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))
• tmax (time from last dosing to maximum measured concentration of the analyte in plasma)(Before each dosing, up to 10 days)
• MRTpo (mean residence time of the analyte in the body at steady state after oral administration)(Before each dosing, up to 10 days)
• Assessment of tolerability by investigator on a 4-point scale(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)(Before each dosing, up to 10 days)
• CLR (renal clearance of the analyte in plasma afer extravascular administration)(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)(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)(Before each dosing, up to 10 days)
• Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)(up to 30 days after drug administration)
• Number of patients with adverse events(up to 51 days)
• Number of patients with abnormal findings in physical examination(up to 30 days after drug administration)
• Number of patients with clinically significant changes in vital signs(up to 30 days after drug administration)