Overall, the results of this thorough QT study indicate that the methodology of the trial was valid and sensitive enough to demonstrate the absence of effect of levocetirizine at both therapeutic (5 mg) and supra-therapeutic (30 mg) doses on cardiac repolarisation.

No abstract

The uricosuric properties of a single oral dose (300 mg) of fenofibrate, or isopropyl-[4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl] propionate (LF 178), a new hypolipidemic drug, have been investigated versus placebo, benzbromarone, with and without urine alkalinization, in ten normouricemic male volunteers, following a crossover design. Twofold increased uric acid clearance values were obtained after fenofibrate and fourfold increased values after benzbromarone. The ratio urinary uric acid/urinary creatinine (UUA/UCr) was enhanced after fenofibrate and benzbromarone versus placebo. The urine alkalinization with fenofibrate intake did increase this ratio to a higher extent.

The study was found to be valid in terms of assay sensitivity and the results demonstrated the absence of effects of brivaracetam on cardiac repolarisation. These results suggest that no intensive cardiac monitoring is required during the subsequent stages of brivaracetam development.

The pharmacokinetics of the H1-receptor antagonist cetirizine were studied from 0 to 72 hours after a single dose of 20 mg in 5 patients with chronic hepatocellular liver disease (group A), in 5 patients with chronic cholestatic liver disease (group B), and in 16 healthy volunteers. The renal function of patients and volunteers was normal (creatinine clearance > or = 70 mL/min). Cetirizine pharmacokinetics were similar in the two groups of patients. The elimination t1/2 was prolonged in patients (mean +/- standard deviation; group A: 14.32 +/- 2.30 hours; group B: 13.86 +/- 3.14 hours) in comparison with the values observed in volunteers (9.42 +/- 2.4 hours). A reduced apparent oral body clearance also was observed in patients (group A: .48 +/- .23 mL/min/kg; group B: .41 +/- .09 mL/min/kg) in comparison with volunteers (.74 +/- .19 mL/min/kg). No differences were observed in the mean cumulative urinary excretion between patients (group A: 69 +/- 15%; group B: 69 +/- 13%) and volunteers (70.7 +/- 7.8%).