Primary Study Endpoints Clause Samples

Primary Study Endpoints. Safety • Complete relief of symptoms of bacterial prostatitis by the final day of therapy • • Culture-negative assessment by the four glass method • Dose: Levofloxacin was well tolerated at the 500 mg/day dose level for the 6 week duration of this study in a Canadian clinical trial.40 The 600 mg/day NM441 dose to be used in this study has been well-tolerated as a multiple dose regimen in Japanese and European clinical trials and in clinical practice in Japan. In a closely-monitored (6.5 day) multiple dose study, the mean plasma concentrations of active metabolite NM394 peaked between 0.5 and 1.0 hours; the maximum concentration was 1.88 mg/mL at a dose of 400 mg/day; the mean half-life was approximately 8.5 hours, and was not affected by the dose. The mean urinary excretion rates of NM394 was 30.6% of the doses within 48 hours at 400 mg/day, and other metabolites were excreted in urine as 7% of the dose. The mean fecal excretion rates of NM394 and NM441 were 52.9 and 4.2%, respectively within 72 hours after dosing of 400 mg. NM441 and NM394 did not accumulate.