Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE® tablet as well as to 400 mg Nevirapine extended release tablet
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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 after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 144 hours after drug administration
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 after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 144 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 144 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 144 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: up to 144 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 144 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 144 hours after drug administration
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ka (absorption rate constant)
Time frame: up to 144 hours after drug administration
Number of patients with adverse events
Time frame: up to 36 days
Number of patients with abnormal changes in laboratory parameters
Time frame: Screening, Day 1, 2, 3, 4, 5, 7, 15
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: Screening, Day 1, 2, 15
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: Screening, Day 1, 15
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 15 days after drug administration