To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)
Time frame: Up to 12 h after the last drug administration of BILR 355
Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Area under the plasma concentration time curve (0-12 hours) (AUC0-12h) for RTV
Time frame: Up to 12 h after RTV administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for RTV
Time frame: Up to 96 h after the last drug administration of BILR 355
Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h,ss)
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Time frame: Up to 12 h after the last drug administration of BILR 355
Number of participants with Adverse Events
Time frame: Up to day 35 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to day 35 after first drug administration
Number of participants with abnormal findings in physical examination
Time frame: Up to day 35 after first drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to day 35 after first drug administration