Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as 4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single dose
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
50 mg
100 mg
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 144 hours post-dose
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 144 hours post-dose
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 (AUC0-tz)
Time frame: up to 144 hours post-dose
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 144 hours post-dose
Terminal rate constant in plasma (λz)
Time frame: up to 144 hours post-dose
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 144 hours post-dose
Mean residence time of the analyte in the body after po administration (MRTpo)
Time frame: up to 144 hours post-dose
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: up to 144 hours post-dose
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 144 hours post-dose
Absorption rate constant (ka)
Time frame: up to 144 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of patients with adverse events
Time frame: up to 35 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 8 days after last trial procedure