The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
1220.49.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
AUCτ,ss of Darunavir
area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Cτ,ss of Darunavir
concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Cmax,ss of Darunavir
maximum measured concentration of the analyte in plasma at steady-state
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Tmax,ss of Darunavir
time from last dosing to maximum concentration of the analyte in plasma at steady state
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
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