Bioequivalence study of telmisartan tablets in healthy volunteers

OBJECTIVE The aim of this research was to evaluate the bioequivalence of telmisartan tablets, imported and domestic tablets, in Chinese healthy volunteers. METHODS A single oral dose 80mg of two telmisartan tablets was given to 18 healthy volunteers in a randomized cross-over study. The concentration of telmisartan in plasma were determined by HPLC with fluorimetric detection. RESULTS Finding revealed that the data of two formulations were fitted to a two-compartment open model. The main pharmacokinetic parameters of two formulations were as follow: C _ max were ( 931.0 ±367.7) μg·L -1 and ( 894.2 ± 421.7 ) μg·L -1 ; T _ max were ( 1.0 ± 0.6 )h and ( 1.4 ± 0.8 )h; t _ 1/2β were ( 28.1 ± 14.1 )h and ( 27.0 ± 10.8 )h; AUC_ 0-t were ( 4 085 ± 2 313 ) μg·L -1 ·h and ( 3 920 ± 2 199 ) μg·L -1 ·h, AUC_ 0-∞ were ( 4 751 ± 2 742 ) μg·L -1 ·h and ( 4 352 ± 2 569 ) μg·L -1 ·h.The relative bioavailability of F _ 0-t and F _ 0-∞ were ( 97.5 ± 15.6 )% and ( 96.5 ± 15.8 )%, respectively. CONCLUSION The results of ANOVA and two one-sided t test statistical analysis showed that two formulations were bioequivalent.