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The pharmacokinetic interaction of ivabradine with ciprofloxacin in healthy volunteers was evaluated. A dose of 5 mg ivabradine in combination with 500 mg ciprofloxacin was administered to 18 healthy male volunteers in a two treatment study design, separated by 6 days in which the ciprofloxacin alone was administrated as a single p.o. dose daily. Plasma concentrations of ivabradine were determined during a 12 hours period following drug administration. Ivabradine plasma concentrations were determined by a validated LC/MS method. Pharmacokinetic parameters of ivabradine were calculated using non-compartmental and compartmental analysis. In the two periods of treatments, the mean peak plasma concentrations (C_max) were 8.52 ng/ml (ivabradine alone) and 8.40 ng/ml (ivabradine after pre-treatment with ciprofloxacin). The times taken to reach C_max, t_max, were 0.86 hr and 1.52 hr respectively and the total areas under the curve (AUC_0-¥) were 27.9 ng.hr/ml and 28.1 ng.hr/ml, respectively. The absorption rate constants (k_a) of ivabradine were 10.8 hr^-1 and 5.27 hr^-1, respectively. Statistically significant differences have been observed for both t_max and k_a of ivabradine when administered alone or with ciprofloxacin, whereas for C_max and AUC_0-¥ the differences were non-significant. The experimental data demonstrate the pharmacokinetic interaction between ciprofloxacin and ivabradine, however, the observed interaction may not be clinically significant.

Keywords: ivabradine, ciprofloxacin, pharmacokinetics, drug interaction