Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the short-term safety of this combination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
(AUC 0-12) Area under the plasma concentration time curve from 0-12 hours
Time frame: up to 12 hours after dose administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 12 hours after dose administration
(C6h) drug concentration in plasma at 6 hours after drug administration
Time frame: up to 6 hours after dose administration
(C12h) drug concentration in plasma at 12 hours after drug administration
Time frame: up to 12 hours after dose administration
Cnh (plasma concentration n hours after drug administration)
Time frame: up to 12 hours after dose administration
Cmax,ss (maximum plasma concentration at steady state)
Time frame: up to 12 hours after dose administration
MRT (mean residence time)
Time frame: up to 12 hours after dose administration
Tmax (time to the maximum plasma concentration)
Time frame: up to 12 hours after dose administration
CL/F (apparent oral clearance)
Time frame: up to 12 hours after dose administration
Vz/F (apparent volume of distribution)
Time frame: up to 12 hours after dose administration
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t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 12 hours after dose administration
Number of subjects with adverse events
Time frame: up to 40 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 40 days