The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses. A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355 (SDS)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
AUC0-inf (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 120 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 120 hours after drug administration
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 120 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 120 hours after drug administration
Tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 120 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 120 hours after drug administration
Number of patients with adverse events
Time frame: up to 10 days after last dose administration
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