PHARMACOKINETICS AND RELATIVE BIOAVAILABILITY OF ANIRACETAM GRANULE IN HEALTHY VOLUNTEERS

OBJECTIVE:Pharmacokinetics and relative bioavailability study of aniracetam granule in healthy volunteers.METHODS:Plasma aniracetam concentrations of 8 Chinese healthy young volunteers after a self alternative single oral dose (600 mg)of aniracetam capsule and granule were detected by RP HPLC.RESULTS:The pharmacokinetic parameters were calculated with 3p87 program by computer.The plasma concentration time curves fitted to a one compartment open model with a first order absorption.Ka were (0.76±0.19)min -1 、(0.348±0.054)min -1 ;t 1/2 were(22.69±2.45)min、(27.78±1.50)min;C max were (61.24±4.15)ng·ml -1 、(76.24±3.60)ng·ml -1 ;T max were (22.94±1.66)min、(11.94±0.58)min;AUC were(3735.78±192.3)ng·min·ml -1 、3754.98±218.5 ng·min·ml -1 .The statistical significance of pharmacokinetic parameters had marked difference(P0.05)except t 1/2 .The relative bioavaiolability of aniracetam granule compared with capsule was 100.52%±2.59%.CONCLUSION:The two preparations were bioequivalent.