Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
AUC (Area under the plasma concentration time curve)
Time frame: up to 7 days
Cmax (Maximum observed concentration of the analyte in plasma)
Time frame: up to 7 days
Tmax (Time of maximum concentration of the analyte in plasma)
Time frame: up to 7 days
T1/2 (Terminal half-life of the analyte in plasma)
Time frame: up to 7 days
Vss/F (Volume of Distribution)
Time frame: up to 7 days
MRT (Mean residence time of the analyte)
Time frame: up to 7 days
CL/F (Apparent clearance of the analyte in plasma)
Time frame: up to 7 days
Number of patients with adverse events
Time frame: up to 21 days
Number of patients with abnormal changes in laboratory parameters
Time frame: Screening, Day 0, Day 7
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