Abstract
Objective. To investigate the pharmacokinetic interaction between ciprofloxacin and itraconazole in healthy male volunteers. Methods. Ten healthy male volunteers were assigned into a 2βsequence, 3βperiod pharmacokinetic interaction study. In phase 1, all subjects were randomly assigned to receive 500βmg of ciprofloxacin alone and 200βmg of itraconazole alone twice daily for 7 days with a 14 day washβout period in a crossover design. Phase 2 was performed 14 days after finishing phase 1, all subjects received 500βmg of ciprofloxacin in combination with 200βmg of itraconazole twice daily for 7 days. Ciprofloxacin and itraconazole pharmacokinetics were studied and adverse effects noted. Results. Ciprofloxacin significantly increased the C~max~ and AUC~0 β β~ of itraconazole by 53.13% and 82.46%, respectively. The halfβlife and CL of itraconazole were not changed significantly. The combination of itraconazole and ciprofloxacin could therefore result in an increase in adverse drug reactions. Conversely, itraconazole had no significant effect on the pharmacokinetics of ciprofloxacin. Conclusion. Ciprofloxacin decreases the metabolism of itraconazole, most likely through inhibition of CYP3A4. The dosage of itraconazole should be reduced and its therapeutic outcome should be monitored closely when these two agents are concomitantly administered. Copyright Β© 2011 John Wiley & Sons, Ltd.