Evaluation of bioequivalence of loratadine capsules in healthy volunteers

OBJECTIVE To evaluate the bioequivalence of loratadine capsules in Chinese healthy volunteers.METHODSA single oral dose 40 mg of two loratadine preparations,reference and test preparation was given to 20 volunteers in a randomized cross-over study.The concentration of loratadine in plasma was determined by solid phase extract HPLC.RESULTSThe main pharmacokinetic parameters of two preparations reference and test preparations were as follows:AUC0-∞were(57.3±20.7) and(60.1±23.7)μg·h·L-1,AUC0-8were(56.5±20.8) and(59.2±23.8)μg·h·L-1,Cmax were(22.9±5.1) and (22.9±5.4)μg·L-1,tmaxwere(0.93±0.20) and(1.06±0.25)h,tmaxwere(1.3±0.4) and(1.2±0.4)h,respectively.The relative bioavailability was(105.0±12.3)%.CONCLUSIONThe results of two one-side test statistical analysis show that the two formulations are bioequivalent.