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Clinical Drug Investigation

, Volume 16, Issue 5, pp 405–410 | Cite as

Lack of Effect of Food on the Bioavailability of Oral Azithromycin Tablets

  • Velimir N. SimicevicEmail author
  • Damit Erceg
  • Csaba Dohoczky
  • Senka Radosevic
  • Radan Spaventi
  • Mauro Buraglio
  • Sergio Canali
  • Josip Culig
Pharmacokinetics

Abstract

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.

Keywords

Adis International Limited Azithromycin Clin Drug Invest Ethylsuccinate Clinical Pharmacology Unit 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Adis International Limited 1998

Authors and Affiliations

  • Velimir N. Simicevic
    • 1
    Email author
  • Damit Erceg
    • 1
  • Csaba Dohoczky
    • 1
  • Senka Radosevic
    • 1
  • Radan Spaventi
    • 1
  • Mauro Buraglio
    • 2
  • Sergio Canali
    • 3
  • Josip Culig
    • 4
  1. 1.Pliva d.d., Research InstituteZagrebCroatia
  2. 2.LCG Bioscience, Clinical Pharmacology UnitBournEngland
  3. 3.Pharmacokinetics and Metabolism UnitLCG Bioscience-RBM, Instituto di Ricerche BiomedicheTorinoItaly
  4. 4.Pliva d.d., Pharmaceutical DivisionZagrebCroatia

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