Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

简要总结

主要结局

次要结局

• Incidence and severity of Adverse events(up to 14 days post treatment)
• Vital signs (blood pressure, pulse rate)(up to 14 days post treatment)
• MRTpo (mean residence time of the analyte in the body after oral administration)(up to 144 hours post treatment)
• Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 144 hours post treatment)
• t1/2 (terminal half-life of the analyte in plasma)(up to 144 hours post treatment)
• 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)(up to 144 hours post treatment)
• %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)(up to 144 hours post treatment)
• λz (terminal rate constant in plasma)(up to 144 hours post treatment)
• Physical examination (occurrence of findings)(up to 14 days post treatment)
• CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)(up to 144 hours post treatment)
• Assessment of tolerability by the investigator(up to 14 days post treatment)
• tmax (time from dosing to maximum measured concentration)(up to 144 hours post treatment)
• 12-lead ECG (electrocardiogram)(up to 14 days post treatment)
• Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis)(up to 14 days post treatment)