Lack of Effect of Food on the Bioavailability of Oral Azithromycin Tablets
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Objective: The purpose of this study was to assess the effect of food on the bioavailability of an oral azithromycin formulation (Sumamed® tablets, Pliva, Zagreb, Croatia
Patients and Methods: Azithromycin was administered as a single oral dose of 500mg (one tablet) to 28 male and female volunteers either in fasting conditions or immediately after 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 volunteers demonstrated a mean maximum plasma concentration (Cmax) about 19% higher than fasting volunteers, but this difference was not statistically significant. Similarly, fed volunteers showed an area under the plasma concentration-time curve about 14% higher than fasting volunteers, which was not statistically different. A statistically significant difference was noted in median time to reach Cmax values between the two groups. However, this finding cannot be considered to be of great importance since the clinical use of azithromycin is not based on its rapid release or action
Conclusion: Administration of azithromycin with a high fat meal did not significantly modify the bioavailability of the 500mg tablet formulation.
KeywordsAdis International Limited Azithromycin Clin Drug Invest Ethylsuccinate Clinical Pharmacology Unit
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