Study on the bioequivalence of domestic loratadine in healthy volunteers
- VernacularTitle:国产氯雷他定片人体生物等效性研究
- Author:
Yu LIU
- Publication Type:Journal Article
- Keywords:
Loratadine;
Bioequivalence;
HPLC
- From:
Journal of Chongqing Medical University
2003;0(05):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the bioequivalence and pharmacokinetics of two kinds of loratadine tablets in 20 healthy volunteers.Methods:An oral dose of 20mg of test or reference loratadine tablets was given according to a randomized 2-way cross-over design,blood samples were withdrawn up to 12 hours past administration,and plasma concentration of loratadine was determined by HPLC method.Results:The peak plasma levels (C max ) of loratadine test drug and reference drug were 8.59?6.70 or 9.59?8.22ng/ml respectively. The peak time (T max ) were 1.08?0.41 or 1.21?0.28h respectively,and AUC 0-t were 27.29?25.54 or 27.12?20.64ng?h/ml respectively.Conclusion:The result of statistic analysis and tow one-sided test suggest that the domestic loratadine talbet is bioequivalent to the imported tablet.The relative bioavailability of domestic loratadine tablets is 100.63%?14.27%.
