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A b s t r a c tBackground: Bisoprolol is one of the most widely used beta-blockers characterised by cardioselectivity, and it has no intrinsic sympathomimetic activity. It is commonly used in the treatment of coronary heart disease and heart failure. Aim:The aim of study was to assess the bioequivalence of the film-coated tablets containing 2.5 mg of bisoprolol (Bisocard ® -the medicinal product) to the original medicinal product (Concor Cor 2.5 ® -the reference). Methods:A randomised, open-label, two-period, crossover, single-dose, relative bioavailability study was conducted in fasted healthy Caucasian volunteers. A single 10-mg oral dose (four tablets of 2.5 mg) of the test or reference product was followed by a 14-day wash-out period, after which the subjects received the alternative product. Blood was sampled within a period of 60 h post administration in pre-specified time points. Bisoprolol concentrations were determined by a validated LC-MS/MS method. The products were considered bioequivalent if the 90% confidence interval (CI) of the log-transformed geometric mean ratios (test vs. reference) for AUC (0-t) , AUC (0-∞) , and C max were within 80-125% limits. Adverse events were monitored during the study based on the subject claims and clinical parameters.Results: Twenty-six healthy male and female volunteers (mean age ca. 29 years; body mass index 22.7 kg/m 2 ) were included in the study, and 24 completed the clinical part. The geometric mean ratios (test/reference) for the log-transformed AUC (0-t) , AUC (0-∞) , and C max were 95.16% (90% CI 92.52-97.87%), 95.08% (90% CI 92.40-97.83%), and 100.00% (90% CI 94.83-105.45%), respectively. There were no significant differences in the pharmacokinetic parameters between the test and reference formulations. No serious adverse events were reported. Conclusions:The results of this single-dose study in healthy Caucasian volunteers indicate that Bisocard ® ; 2.5 mg film-coated tablets are bioequivalent to the reference product -Concor Cor 2.5 ® ; 2.5 mg film-coated tablets. Both products had similar safety profile and have been well tolerated.

The results of the single-dose study in healthy white volunteers indicated that the film-coated tablets of Bisocard® 10 mg manufactured by ICN Polfa Rzeszów S.A. (test formulation) are bioequivalent to those of Concor 10® manufactured by Merck KGaA (reference formulation). Both formulations were well tolerated.