EFFECT OF FOOD ON PHARMACOKINETICS OF AZITHROMYCIN

The primary objective of the study was to investigate the effect of food on the pharmacokinetics of Azithromycin. Cmax, Tmax and AUC of Azithromycin were defined as the main parameters for the assessment of bioavailability and bioequivalence of Azithromycin administered in fasting and fed conditions. The 90% CI for the fed/fasting Azithromycin did not contained within the acceptance interval (80, 125) and, therefore, it can be concluded that the rate of systemic exposure to Azithromycin does not fit the claim of bioequivalence between administration in fasting and fed conditions. This study has demonstrated that all the pharmacokinetic parameters of both the treatments were statistically different from each other. In the fed condition the values of Cmax and AUC were decreased while Tmax increases than that of fasting which demonstrated that the extent of systemic exposure to Azithromycin was affected by the delay in absorption of Azithromycin in the pre sence of food. None of the study volunteers reported any serious adverse effects throughout the study. The only two AEs reported were mild and not related to the study medication. The AEs reported were, according to the study medical expert, related to the sampling procedure and were self limiting and did not require any treatment. There was no change in the vital signs of the volunteers throughout the study period. The presented data are of major importance in identifying the optimal dosing regimen for future clinical trials with oral Azithromycin. In our study, only one type of food (a standardized continental breakfast) was evaluated; further studies are needed to assess the effects of foods with different compositions and contents on the bioavailability of Azithromycin.