Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food versus without food.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AUC0-∞ (area under the concentration time curve of tipranavir in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours after drug administration
Cmax (maximum concentration of tipranavir in plasma)
Time frame: up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of tipranavir in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of tipranavir in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of tipranavir in plasma)
Time frame: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CLpo/F (apparent clearance of tipranavir in the plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to day 18
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