Studies on pharmacokinetics and bioequivalence of telmisartan in healthy volunteers

OBJECTIVE To study the pharmacokinetics profiles of telmisartan and observe the bioavailability of domestic telmisartan tablet and capsule METHODS A triple cross experiment design was conducted 18 healthy volunteers were given a single dose of 80 mg telmisartan after divided into 3 groups randomly The wash out period was 12 d HPLC method was applied to analyze telmisartan concentration in plasma RESULTS The main pharmacokinetics parameters of three preparations(tablet,capsule and reference) were as follow: c max were(812 16±110 65),(819 54±129 97)and(855 37±92 27)ng·mL -1 ; t max were(0 99±0 43),(0 83±0 36)and(1 15±0 61)h; t 1/2 were(19 3±7 0),(19 5±2 9)and(18 6±3 9)h;AUC 0～72 were (4 181 43±2 536 14),(3 785 63±2 477 71)and(3 874 48± 1 981 11 )ng·h·mL -1 , respectively The bioavailability of tablet and capsule were (106 87±16 17)% and(97 69±20 65)%, respectively CONCLUSION The pharmacokinetic figures were weighed with ANOVA,two one sided t test and 90% confidence interval and the results showed the two domestics preparations were both bioequivalent compared with the imported tablet