Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl

Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap ® and Mikardis was conducted with 60 volunteers. Aim. The purpose the trial comparative pharmacokinetics evidence (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, Germany) Zentiva KS company, Czech Republic) healthy volunteers after single administration under fasting. Materials methods. To prove bioequivalence, an open label, comparative, randomized, crossover four-period replicate single-center conducted. concentrations telmisartan plasma samples were determined by validated HPLC-MS/MS method. pharmacokinetic statistical analysis performed confidence intervals for parameters C max AUC 0-72 calculated. Results discussion. can be concluded that studied formulations are bioequivalent terms test reference drug. All 90 % within range 80–125 73,07–136,85 . Conclusion. Thus, according to criteria study, proved bioequivalent.