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Comparison of bisoprolol pharmacokinetics after 10 mg oral administration of Bisocard and reference formulation to healthy subjects

Katarzyna Buś-Kwaśnik 1Hanna Ksycińska 1Andrzej Leś 1,2Krystyna Serafin-Byczak 1Piotr J. Rudzki 1Jerzy Raszek 3Tomasz Łazowski 3,4Agnieszka Bielak 5Andrzej Wybraniec 5

1. Pharmaceutical Research Institute (IF), Rydygiera 8, Warszawa 01-793, Poland
2. Warsaw University Faculty of Chemistry, Warszawa 02-093, Poland
3. Clinical Centre CRO Poland Sp. z o.o., Otwock 05-400, Poland
4. Medical University of Warsaw first Department of Anaesthesiology and Intensive Care, Warszawa 02-005, Poland
5. ICN Polfa Rzeszów S.A., Rzeszów 35-959, Poland


Bisoprolol, 1-(propan-2-ylamino)-3-[4-(2-propan-2-yloxyethoxymethyl)phenoxy]- propan-2-ol is a synthetic a highly selective beta1-adrenoceptor antagonist. Bisoprolol reduces the heart rate and is useful in treating abnormally rapid heart rhythms. It also reduces the force of contraction of the heart and lowers blood pressure.
The aim of the study was to compare pharmacokinetics of bisoprolol observed in two separate bioequivalence studies. The test products were Bisocard 10 mg and Bisocard 2.5 mg film-coated tablets, both manufactured by ICN Polfa Rzeszów S.A. The reference products were Concor 10® and Concor COR 2.5 film-coated tablets, both manufactured by Merck KGaA, Beerse, Belgium. Bisoprolol concentration in plasma samples was determined using LC-MS/MS method at the Good Laboratory Practice certified laboratory of the Pharmacology Department, Pharmaceutical Research Institute.
The results indicated that generic and branded formulations were bioequivalent at both doses. In both studies the 90% CI for geometric mean test/reference-ratios for the primary pharmacokinetic parameters (AUC(0-t), AUC(0-) and Cmax) were within acceptance limits of 80.00 – 125.00%. The secondary parameters (tmax, t1/2, MRT) recorded in both studies were comparable.
The study was supported by ICN Polfa Rzeszów.


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Submitted: 2012-04-13 08:58
Revised:   2012-04-16 07:53