Abstract:
Objective: To investigate the bioequivalence of zidovudine 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 zidovudine in serum was determined by HPLC,and pharmacokinetic parameters were calculated with DAS 2.0 practical pharmacokinetics program.
Results: The pharmacokinetic parameters of zidovudine tablets and capsules were as follows:t
1/2(0.909±0.308) h and(0.987±0.234) h,C
max(1.723±0.870) μg/ml and(1.457±0.578) μg/ml,T
max(0.90±0.69) h and(0.80±0.41) h,AUC
0-8h(2.302±0.503) μg·h
-1·ml
-1 and(2.361±0.567) μg·h
-1·ml
-1.The relative bioavalibility of zidovudine tablets was(100.8±25.8)%.
Conclusions: The statistical analysis shows that the test and reference preparation are bioequivalent.