Bioequivalence study of telmisartan tablets in healthy volunteers

Objective To study the bioequivalence of telmisartan tablets in healthy volunteers.Methods Telmisartan concentrations in serum were determined by LC-MS after a single oral dose of 80mg of telmisartan tablet or reference telmisartan tablet was given to 20 healthy male volunteers in an randomized cross-over design.The pharmacokinetic parameters and relative bioavailability were calculated by SPSS program to evaluate the bioequivalence of two preparations. Results AUC_(0→96) of reference and test drug were 2910.5± 289.6 and 2866.8± 235.5 μ g·h·L~(-1), C_(max) were 347.2± 41.1 and 352.4± 42.9 μ g·L~(-1), t_(max) were 1.1± 0.25 and 1.1± 0.21 h, respectively. Conclusion The 2 preparations are bioequivalent.The relative bioavailability of the test drug was (98.9± 7.0)%. The two preparations are bioequivallent.