To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of tipranavir/r on BILR 355 BS pharmacokinetics
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Area under the concentration-time curve of tipranavir and BILR 355 BS in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)
Time frame: up to 18 days after start of treatment
Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)
Time frame: up to 18 days after start of treatment
Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss)
Time frame: up to 18 days after start of treatment
Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss)
Time frame: up to 18 days after start of treatment
Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss)
Time frame: up to 18 days after start of treatment
Apparent volume of distribution of BILR 355 BS, tipranavir and ritonavir during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)
Time frame: up to 18 days after start of treatment
Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h)
Time frame: up to 18 days after start of treatment
Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss)
Time frame: up to 18 days after start of treatment
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Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss)
Time frame: up to 18 days after start of treatment
Number of participants with clinically relevant changes in laboratory parameters
Time frame: up to 28 days after start of treatment
Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 28 days after start of treatment
Number of participants with clinically relevant changes in 12-lead ECG
Time frame: up to 14 days after start of treatment
Number of participants with adverse events
Time frame: Up to 7 weeks