LACK OF EFFECT OF FOOD ON THE BIOAVAILABILITY OF ORAL AZITHROMYCIN TABLETS

Objective: The purpose of this study was to assess the effect of food on the bioavailability of an oral azithromycin formulation (Sumamed(R) tablets, Pliva, Zagreb, Croatia). Patients and Methods: Azithromycin was administered as a single oral dose of 500mg (one tablet) to 28 mal e and female volunteers either in fasting conditions or immediately af ter a standard high fat breakfast. The study design was single-centre, open, randomised, single-dose, two-period, food and fasting crossover , with a washout between the study periods of 3 weeks. Results: Fed vo lunteers demonstrated a mean maximum plasma concentration (C-max) abou t 19% higher than fasting volunteers, but this difference was not stat istically significant. Similarly, fed volunteers showed an area under the plasma concentration-time curve about 14% higher than fasting volu nteers, which was not statistically different. A statistically signifi cant difference was noted in median time to reach C-max values between the two groups. However, this finding cannot be considered to be of g reat importance since the clinical use of azithromycin is not based on its rapid release or action. Conclusion: Administration of azithromyc in with a high fat meal did not significantly modify the bioavailabili ty of the 500mg tablet formulation.