A STUDY ON BIOEQUIVALENCE OF LORATADINE TABLETS AND CAPSULES

Objective To evaluate whether it was of bioequivalence between tested loratadine tablets , capsules and market sale loratadine tablets(clarityne), so as to provide the trial evidence for declaring the new drug and its clinical application. Methods Single dose of 20 mg of domestic loratadine tablets or capsules or imported loratadine(clarityne) was given to 18 healthy male volunteers. The blood samples were detected for its concentration, before and at 0.33, 0.67, 1.00, 1.50, 2.00, 3.00, 4.00 , 6.00, 8.00, 12.00, 24.00 hours after medication, by LC/MS/MS method. The pharmacokinetic parameters were calculated and bioequivalence of tested and market sale loratadine evaluated. Results The main pharmacokinetic parameters of loratadine tablets and capsules and imported loratadine(clarityne) were as follows: AUC 0～ t : 38.79, 38.40 and 37.02 g·h·L -1 ; C max : 13.73 , 13.76 and 13.91 μg/L; T max : 1.33, 1.17 and 1.24 h; T 1/2 : 4.43, 4.90 and 4.38 h, respectively. There were no significant differences in the parameters between the tested and comparative preparations. The relative bioequivailability of domestic loratadine tablets and capsules was 104.78% and 103.73%, respectively. Conclusion The results of statistical analysis showed that the tested and comparative preparations were bioequivalence.