Comparison of effect of fasting and of five different diets on the bioavailability of single oral dose of clarithromycin 500 mg extended release tablet
{"title":"Comparison of effect of fasting and of five different diets on the bioavailability of single oral dose of clarithromycin 500 mg extended release tablet","authors":"S. Gurule, T. Monif, P. Verma, A. Khuroo","doi":"10.3109/10601330903252198","DOIUrl":null,"url":null,"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.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"15 1","pages":"73 - 83"},"PeriodicalIF":0.0000,"publicationDate":"2009-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601330903252198","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1
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.