Comparison of effect of fasting and of five different diets on the bioavailability of single oral dose of clarithromycin 500 mg extended release tablet

Abstract

The objective of this cross-over bioavailability study on clarithromycin was to compare the bioavailability under fasting and five different diets, in 18 healthy adult male human volunteers using validated LC-MS/MS method. A single dose of clarithromycin 500 mg extended release tablet was administered at six occasions: after overnight fasting, after two vegetarian diets (high fat and low fat), two non-vegetarian diets (high fat and low fat), and low fat vegetarian rice. Serial blood samples were collected up to 36 h after dose. A statistically significant food effect was observed for all diets when compared to fasting treatment.

Keywords::

• Clarithromycin
• LC-MS/MS
• bioavailability

Acknowledgement

This paper is part of PhD thesis of Sanjay Gurule. The author thanks Ranbaxy research labs, Gurgaon, India, for carrying out this work.

Declaration of interest: The authors report no conflict of interest.