Abstract: AIM: To study the pharmacokinetics and relative bioavailability of irbesartan tablets.METHODS: A single oral dose of 300mg irbesartan of reference or test tablet was given to each of 18 male healthy volunteers according to an open randomized crossover design.The concentrations of irbesartan in plasma were determined by HPLC.RESULTS: The main pharmacokinetic parameters of irbesartan showed that C_max were (3147±922) and (2856±652) ng/mL, tmax were (1.6±0.7) and (1.9±1.1) h, AUC_0→t were (17559±7482) and (17366± 5498) ng°mL^-1°h, AUC_0→∞ were (18276±7710) and (18284±5336) ng°mL^-1°h for reference or test tablet respectively.There was no significant difference between the parameters of two tablets.CONCLUSION: The relative bioavailability of test tablet to reference tablet is 101%±32%.The results of statistical analysis show that two formulations are bioequivalent.

Key words: irbesartan, bioequivalence, HPLC