Pharmacokinetics and Bioequiavailability of Loratadine Tabletes in Healthy Volunteers

OBJECTIVE:To evaluate the bioequiavailability of two kinds of loratadine tabletes in Chinese healthy volunteers.METHODS:A single oral dose 40 mg of two loratadine preparations(reference and test preparations)was given to 20 volunteers(whom were divided into two groups)in a randomized cross-over study.The concentration of loratadine in plasma was determined by solid phase extraction-HPLC.RESULTS:The main pharmacokinetic parameters of reference and test preparations were as follows:Cmax were(17.00±3.90)and(18.41±2.58)μg·L-1;tmax were(1.06±0.25)and(0.93±0.20)h;t1/2Ke were(1.34±0.38)and(1.08±0.38)h;AUC0～∞ were(37.41±17.38)and(36.38±16.73)μg·h·L-1;AUC0～8 were(35.11±15.72)and(34.76±15.34)μg·h·L-1,respectively.The relative bioavailability of the test preparation was(99.0±18.7)% as against the reference preparation,and no significant differences was noted for the two formulations in ANOVA and two-one side t test.CONCLUSION:The two formulations were bioequivalent.