Phase I study of new non-steroidal antiinflammatory drug, CS-670.
摘要
A new non-steroidal anti-inflammatory drug, CS-670 was given orally in varying doses to healthy male volunteers for the study of safety and pharmacokinetics.The following results were obtained:1) After single (5, 15, 30, 60 and 120mg), divided (180mg/dose, 3 times a day), and multiple (180mg/dose, 3 times a day for 7 days) administrations, no abnormal clinical signs and laboratory examination values attributable to the drug were observed.2) CS-670 and its four major metabolites, trans-OH, cis-OH, unsaturated-OH, and saturated keton, in plasma or urine specimens were separated using Bone Elut®C8 column and quantified with high-performance liquid chromatography.3) The pharmacokinetic parameters didn't change between administration before meal and after meal.4) After multiple administration of CS-670 three times a day for seven days, plasma concentration and urinary excretion of CS-670 and its metabolites were not significantly different from single administration. Plasma levels of CS-670 and its metabolites reached a steady state at first day.