Study to determine the relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
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 144 hours post-dose
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 144 hours post-dose
C24 (measured concentration of the analyte in plasma at 24 hours post-dose)
Time frame: 24 hours post-dose
Cmax/C24 ratio
Time frame: up to 144 hours post-dose
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 144 hours post-dose
λz (terminal rate constant in plasma)
Time frame: up to 144 hours post-dose
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 144 hours post-dose
MRTpo (mean residence time of the analyte in the body after po administration) CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 144 hours post-dose
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 144 hours post-dose
ka (absorption rate constant)
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Time frame: up to 144 hours post-dose
Number of patients with adverse events
Time frame: up to 36 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 8 days after last trial procedure
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 144 hours post-dose