Relative Bioavailability of Both BI 10773 and Glimepiride After Co-administration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and a Single Dose of Glimepiride (1 mg) Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)

简要总结

主要结局

次要结局

• λz (terminal rate constant in plasma) of glimepiride(up to 4 days)
• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) of glimepiride(up to 4 days)
• tmax (time from dosing to the maximum concentration of the analyte in plasma) of glimepiride(up to 4 days)
• t½ (terminal half-life of the analyte in plasma) of glimepiride(up to 4 days)
• MRTpo (mean residence time of the analyte in the body after po administration) of glimepiride(up to 4 days)
• CL/F (apparent clearance of the analyte in the plasma after extravascular administration) of glimepiride(up to 4 days)
• Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of glimepiride(up to 4 days)
• MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773(up to 5 days)
• CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773(up to 5 days)
• Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 10773(up to 5 days)
• Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ) of BI 10773(1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5)
• fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ) of BI 10773(1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5)
• CLR,ss (renal clearance of the analyte at steady state) of BI 10773(1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5)
• UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h)(1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on days 1 and 5)
• Number of patients with abnormal findings in physical examination(Baseline and within 3-14 days after last glimepiride administration)
• Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)(Baseline, day 1 and within 3-14 days after last glimepiride administration)
• Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)(Baseline, day 1 and within 3-14 days after last glimepiride administration)
• Number of patients with abnormal findings in clinical laboratory tests(Baseline, day 1,4 and within 3-14 days after last glimepiride administration)
• Number of patients with adverse events(Up to 34 days)
• Assessment of tolerability by investigator on a 4-point scale(Within 3-14 days after last glimepiride administration)
• Number of patients with abnormal findings in glucose bedside tests(Pre-dose and 1, 2, 4, 7, 10, 14, 24 hours after glimepiride administration on day 1)
• tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773(up to 5 days)
• Aet1-t2 (amount of analyte eliminated in urine over the time interval from t1 to t2) of glimepiride(1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1)
• fet1-t2 (fraction of analyte excreted unchanged in urine over the time interval from t1 to t2) of glimepiride(1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1)
• CLR (renal clearance of the analyte) of glimepiride(1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1)
• λz,ss (terminal rate constant of analyte in plasma at steady-state) of BI 10773(up to 5 days)
• t½,ss (terminal half-life of analyte in plasma at steady-state) of BI 10773(up to 5 days)