Pharmacokinetic and bioequivalence study of Telzap® Plus fixed-dose combination compared with MikardisPlus® in healthy volunteers after single administration

Introduction. A fixed dose combination of telmisartan and hydrochlorothiazide is indicated for treatment in the arterial hypertension. The these substances causes an additive effect that helps to reduce blood pressure. bioequivalence study Telzap ® Plus compared with MikardisPlus was conducted 63 volunteers. Aim. purpose trial a comparative pharmacokinetics evidence drug product (tablets 80 mg + 12,5 mg, Zentiva KS company, Czech Republic) products (telmisartan+hydrochlorothiazide, tablets Boehringer Ingelheim Pharma GmbH & Co. KG, Germany) healthy volunteers after single administration under fasting. Materials methods. To prove bioequivalence, open label, comparative, randomized, crossover fourperiod replicate single-center clinical conducted. concentrations plasma samples were determined validated HPLC-MS/MS method. pharmacokinetic statistical analysis performed confidence intervals parameters C max AUC 0-72 calculated. Results discussion. It can be concluded studied formulations are bioequivalent terms telmisartan. All 90 % estimated range 80–125 %, within , 79,30–126,11 . Conclusion. Thus, according criteria used study, proved bioequivalent.