Phase I Study of CT-848 (The 1st Report). The Study in Single Oral Administration.:The Study in Single Oral Administration

概要

論文の詳細を見る
The tolerability and kinetics of a new cerebral function activator, oxiracetam (CT-848), after single oral administration (dose: 400, 800, 1, 600 and 3, 200mg) was investigated in 8 healthy Japanese volunteers (active drug, 6; placebo, 2).At the same time, the effect of food on the kinetics of oxiracetam was investigated after single dosing (800mg) in the same volunteers.As subjective symptoms, sleepiness and heaviness in the head were observed after active drug and placebo administration, but were slight and transient. Clinical laboratory test values and vital signs were not notably changed with oxiracetam administration.Peak plasma levels were reached within approximately 1hr (Tmax) after administration of 400, 800, 1, 600 and 3, 200mg (Cmax): 11.89, 18.82, 43.11 and 72.64μg/ml, respectively, and the biological half-life of the β-phase was 5.7-9.8hr under fasting conditions. The average recovery (0-48hr) in urine was 57-77% after dosing.While the Tmax of oxiracetam was significantly altered in fasting volunteers and in volunteers after a meal, AUC, Cmax and urinary excretion were not significantly changed.The above results confirm the safety of oxiracetam given as a single oral administration to healthy Japanese volunteers.
一般社団法人日本臨床薬理学会の論文