Relative bioavailability of telmisartan tablets

Objective To evaluate the pharmacokinetics and relative bioavailability of telmisartan tablets imported(test)versus locally manufactured(reference). Methods Eighteen healthy male volunteers were randomly administered a single crossover dose of 80 mg test and reference tablets.Plasma telmisartan concentration was determined by HPLC-Fluorescent.The relative bioavailability and bioequivalence of the tablets were analyzed using the 3p97 program. Results The pharmacokinetic parameters of test and reference tablets were as follows:tmax(1.25±0.48)vs.(1.17±0.49)h,ρmax(3.38±1.92)vs.(3.27±1.80)mg·L-1,t1/2(29.0±8.64)vs.(27.0±7.93)h,AUC0-t(21.27±14.82)vs.(21.13±12.59)mg·h·L-1,AUC0-∞(23.43±17.74)vs.(22.93±14.67)mg·h·L-1.The relative bioavailability of the test formulation was(99.1±16.9)%. Conclusions The test tablets are bioequivalent to the reference tablets.