1. To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials 2. To investigate the relative BA of the pediatric suspension, compared to the current 1B formulation 3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three 25mg tablets vs. one 75 mg tablet, current 1B formulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 96 hours after drug administration
Cmax (maximum measured concentration of analyte in plasma)
Time frame: Up to 96 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 time of the last quantifiable data point)
Time frame: Up to 96 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: Up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 96 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: Up to 96 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 96 hours after drug administration
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Number of participants with clinically significant changes in vital signs
Time frame: Up to day 43 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to day 43 after first drug administration
Number of participants with Adverse Events
Time frame: Up to day 43 after first drug administration