Common use of Study parameters Clause in Contracts

Study parameters. Plasma concentrations of the active metabolite (NM394) will be determined in blood samples collected before the administration (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 18, and 24 h after dosing. Urine samples will also be collected. Determination in biological samples will be performed using validated and specific HPLC methods. The following parameters will be calculated: Cmax, tmax, ▇▇▇▇-▇, ▇▇▇▇-▇▇, ▇▇/▇, ▇/▇, ▇▇▇▇, ▇▇▇▇▇, and fe. • Objectives: To determine the safety, tolerability, pharmacokinetics, and comparative efficacy of NM441 versus levofloxacin in patients with chronic bacterial prostatitis, following a series of oral doses for 42 consecutive days. •