To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration. In each case, 500 mg tipranavir was coadministered with 200 mg ritonavir.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
AUC0-∞ (area under the concentration-time curve of drug in plasma over the time interval from 0 extrapolated to infinity) for tipranavir
Time frame: up to 72 hours after drug administration
Cmax (maximum measured concentration of drug in plasma) for tipranavir
Time frame: up to 72 hours after drug administration
AUC0-∞ for ritonavir
Time frame: up to 72 hours after drug administration
Cmax for ritonavir
Time frame: up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of drug 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 drug in plasma)
Time frame: up to 72 hours after drug administration
λz (terminal rate constant of drug in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of drug in plasma)
Time frame: up to 72 hours after drug administration
MRTpo (mean residence time of drug in the body after oral administration)
Time frame: up to 72 hours after drug administration
CLpo/F (apparent clearance of drug after oral administration)
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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 patients with adverse events
Time frame: up to 43 days
Number of patients with clinically significant findings in vital signs
Time frame: up to 43 days
Number of patients with clinically significant findings in 12-lead electrocardiogram
Time frame: up to 43 days
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 43 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 4 of each treatment period