Abstract:
Objective: To investigate the bioequivalence of valsartan dispersible tablets and capsules in healthy volunteers.
Methods: Twenty volunteers were randomly divided into two groups(test and reference),with double cross-over design.The concentration of valsartan in serum was determined by high performance liquid chromatography(HPLC) and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.
Results: The pharmacokinetic parameters of valsartan dispersible tablets and capsules were as follows:t
1/2 were(3.715±1.895)h and(3.585±1.901)h,C
max were(1.797±0.539)μg/ml and(1.848±0.647)μg/ml,T
max were(2.350±0.489)h and(2.425±0.438)h,AUC
0-36 h were(10.786±3.794) μg·h
-1·ml
-1 and(10.52±3.96) μg·h
-1·ml
-1.The relative bioavalibility of valsartan dispersible tablets was(111.6±40.7)%.
Conclusions: The statistical analysis showed that the test and reference preparation were bioequivalent.