TABLE 4

Pharmacokinetic steady-state plasma parameters from simulated intravenous administration of 800 mg finafloxacin per daya

ParameterMedian value for trial (95% prediction interval)
IIIII
AUC (mg · h/liter)38 (15–96)54 (22–134)
AUCW (mg · h/liter)39 (15–101)53 (19–143)
Cmax (mg/liter)14 (9–23)16 (10–27)
Tmax (h)1.12 (1.01–1.37)1.13 (1.01–1.45)
T1/2 (P) (h)1.66 (0.67–4.0)2.15 (0.87–5.27)
T1/2 (T) (h)12.5 (6.21–25.2)13.3 (6.5–27.1)
  • a Shown are plasma predictions (medians and 95% prediction intervals) of the AUC normalized to a body weight of 75 kg (AUCW), the maximum attained concentration (Cmax), the time at which the maximum concentration was reached (Tmax), as well as plasma (P) and terminal (T) elimination-half-lives (T1/2) given a simulated intravenous administration of 800 mg finafloxacin per day at steady state. Presented values were calculated via a Monte Carlo simulation using covariate data from all healthy volunteers from trial II and data from all patients from trial III.