A Pharmacokinetic Study of Ivabradine and Bisoprolol Combination in Healthy Volunteers

Abstract

A comparative randomized open-label three-period crossover study of ivabradine/ bisoprolol in male healthy human volunteers. The aim of this study was to undergo a pharmacokinetic study to investigate the incidence of potential pharmacokinetic interaction between Ivabradine and Bisoprolol through the Assessment of the drug-drug interactions of Ivabradine and Bisoprolol by determination of pharmacokinetic parameters of both drugs administered alone and in combination. The pharmacokinetic parameters were included, The maximum plasma concentration (Cmax),the time to reach the peak concentration (tmax), area under the concentration–time curve (AUC0-t) and (AUC0-∞) during the treatment periods, the absorption and elimination rate constants (ka and kel), the half-life and mean residence time (MRT) Eighteen healthy volunteer was recruited in the study and will be divided into three groups each consisting of six volunteers as follows: Period I: • Group A: Six Volunteers were received single 10 mg oral dose of ivabradin (Procoralan®, Les Laboratoires Servier Industrie-France). • Group B: Six Volunteers were received single oral dose of bisoprolol 5mg (Concor®). • Group C: Six Volunteers were received a single dose of ivabradine 10 mg and bisoprolol 5 mg