Relative bioavailability of domestic and imported telmisartan tablets in healthy volunteers

OBJECTIVE To study the bioavailability of domestic and imported telmisartan tablets and evaluate its bioequivalence in healthy volunteers.METHODS A single oral dose of 80 mg domestic and imported telmisartan tablets was given to 24 healthy male volunteers according to an open randomized 2 way crossover design. The plasma concentration of telmisartan was determined by a HPLC assay. RESULTS The pharmacokinetic parameters of the two products were as follows: tmax(0.82±0.33) and (0.81±0.20)h,ρmax(560.94±229.23) and (602.75±212.71)μg·L-1,AUC0-t(3 231.42±1 353.49) and (3 304.46±1 308.97)μg·h·L-1, respectively.The relative bioavailability of domestic product was (98.2±11.5)% .CONCLUSION Two preparations were bioequivalence.