Objective To study the bioequivalence of the tested and reference oral candesartan Cilexetil in healthy male volunteers. Methods According to the crossover design,each volunteer was orally given 8 mg candesartan cilexetil capsules or tablets. Their plasma concentrations were determined by LC/MS/MS. Pharmacokinetic parameters were obtained using DAS program. Results Cmax were(79.62±29.99) ng/ml and (77.74±28.46) ng/ml,AUC0-t were (850.17±249.52) ng/(ml· h)and (837.26±243.26)ng/(ml· h),AUC0-∞ were (908.96±249.64) ng/(ml· h) and(896.94±241.53) ng/(ml· h),respectively. Two-way unilateral t-test results showed that the test preparation did not exceed the prescribed upper limit and lower limit of the reference preparation, rejected null hypothesis (P＜0.05). The 90% confidence intervals of Cmax,AUC0-t and AUC0-∞were between the standard of reference tablets (80%-125%). Conclusions Candesartan cilexetil capsules and candesartan cilexetil tablets are bioequivalent.
Key words
candesartan cilexetil /
bioequivalence /
pharmacokinetic parameters
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