Abstract: AIM: To investigate the pharmacokinetics and bioequivalence of candesartan cilexetic tablets, capsules and imported tablets in healthy volunteers.METHODS: A single oral dose 16 mg of three formulations was randomly given to 18 healthy volunteers in a three cycle duplex 3×3 latin square crossover design.The concentration of candesartan in plasma, which is a major metabolite of candesartan cilexetic, was determined by HPLC-FLD at different times. The pharmacokinetics parameters were calculated and the bioequivalence of three formulations were evaluated by DAS program.RESULTS: The main pharmacokinetic parameters of candesartan cilexetic tablets, capsules and imported tablets were as follows:t_max were (4.6±0.9), (4.6±1.3)and (4.4±0.9)h, t_1/2 were(8.8±1.9), (8.3±1.9), (8.5±1.8)h, C_max were(170±61), (155±75)and (171±77)ng°mL, AUC_0-36 were(1762±576), (1684±600)and (1808±662)ng°mL^-1 °h, AUC_0-∞ were (1886±616), (1776±600)and (1913±694)ng°mL^-1 °h.The relative bioavailability of tested tablets and capsules were 97.75% and 93.11%.CONCLUSION: The two tested formulations are bioequivalent with reference formulation.

Key words: candesartan cilexetic, candesartan, HPLC-FLD, pharmacokinetics, bioequivalence