Study on Bioequivalence of Flunarizine Capsules in Healthy Volunteers

A single administration of 20mg domestic and reference flunarizine capsules were given to two group of 20 healthy male volunteers in randomized crossover study respectively. A high performance liquid chromatographic assay with fluorimetric detection was developed to determine the concentration of flunarizine in human serum. The data were analyzed by 3P97 program. The pharmacokinetics parameters after a single oral administration of 20mg domestic and reference products were as follows: Cmax54.75±14.52μg.L-(-1)and 52.20±13.04μg.L-(-1);tmax2.40±0.45 h and 2.33±0.44h; AUC_(0-24)256.56±42.32μg.L-(-1).hand 248.81±37.43μg.h.L-(-1); AUC_(0－∞）275.87± 45.62μg.h.L-(-1)and 267.48±40.10μg.h.L-(-1);respectively. Variance analysis and two one-sided test were performed to palameters: Cmax AUC_(0-24)andAUC_(0-∞）There was no significant difference. The two preparations were of bioequivalence, the relative bioavailabilities of single oral administration group was 103.29±9.36%.