Phase I Study of CT-848 (The 2nd Report). The Study in Multiple Oral Administration.:The Study in Multiple Oral Administration

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A new cerebral function activator, oxiracetam (CT-848), was given orally by multiple t. i. d. administrations of 800mg to 8 healthy Japanese volunteers for 8 days (active drug, 6; placebo, 2), and its tolerability and pharmacokinetics studied.As subjective symptoms, constipation and heaviness in the head were observed after administration, but were slight and transient.Clinical laboratory test values and vital signs were not notably changed with oxiracetam administration.The unchanged plasma concentration reached a constant level on the 2nd day. Plasma level elimination patterns after final administration was practically the same as after single administration.There was no significant difference in the cumulative amounts of urinary excretion over 24hr when measured from the first to the 7th days of drug administration.Accumulation of the drug was not observed with multiple administration, and oxiracetam had a good tolerability profile in healthy volunteers.
一般社団法人日本臨床薬理学会の論文