Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and TRUVADA on BILR 355
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Area under the concentration-time curve from 0 to 24 hours at steady state of the analyte in plasma (AUC0-24h,ss)
Time frame: up to 24 h after treatment
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
Time frame: up to day 18 after start of treatment
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: up to day 18 after start of treatment
Measured concentration of the analyte in plasma 24 hours post last dose at steady state (Cp24h, ss)
Time frame: up to 24 h after treatment
Terminal half-life of of the analyte in plasma in the plasma at steady state (t1/2, ss)
Time frame: up to day 18 after start of treatment
Apparent volume of distribution of of the analyte in plasma during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)
Time frame: up to day 18 after start of treatment
Area under the concentration-time curve from 0 to 24 hours of ritonavir in plasma (AUC0-24h)
Time frame: up to 24 h after treatment
Maximum measured concentration of ritonavir in plasma (Cmax)
Time frame: up to 24 h after treatment
Number of subjects with clinically relevant changes in clinical laboratory tests
Time frame: up to day 28 after start of treatment
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Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time frame: up to day 28 after start of treatment
Number of subjects with adverse events
Time frame: Up to 7 weeks