Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects.

Filed under: Drug and Alcohol Rehabilitation

Drug Des Devel Ther. 2012; 6: 311-6
Tjandrawinata RR, Setiawati E, Yunaidi DA, Santoso ID, Setiawati A, Susanto LW

The present study was conducted to compare the bioavailability of two bisoprolol fumarate 5 mg film-coated tablet formulations (test and reference formulations).This study was a randomized, single-blind, two-period, two-sequence crossover study that included 18 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were determined based on the concentrations of bisoprolol (CAS 66722-44-9), using ultraperformance liquid chromatography with a tandem mass spectrometer detector. In each of the two study periods (separated by a washout of 1 week) a single dose of test or reference product was administered. The pharmacokinetic parameters assessed were area under the plasma concentration-time curve from time zero to 48 hours (AUC(t)), AUC from time zero to infinity (AUC(inf)), the peak plasma concentration of the drug (C(max)), time needed to achieve C(max) (t(max)), and the elimination half-life (t(½)).The geometric mean ratios (90% confidence intervals) of the test drug/reference drug for bisoprolol were 101.61% (96.14%-107.38%) for AUC(t), 101.31% (95.66%-107.29%) for AUC(inf), and 100.28% (93.90%-107.09%) for C(max). The differences between the test and reference drug products for bisoprolol t(max) and t(½) values were not statistically significant (P > 0.05).… Continue reading →