Lack of Effect of Food on the Bioavailability of a New Ketolide Antibacterial, Telithromycin
| Autor: | Catherine Perret, E. Sultan, G. Montay, Bernard Lenfant, Marie-Helene Pascual, Vijay O. Bhargava |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Male Microbiology (medical) Ketolides Adolescent Telithromycin Statistical difference Biological Availability Pharmacology Single oral dose Food-Drug Interactions Pharmacokinetics medicine Humans Fasting state Ketolide Cross-Over Studies General Immunology and Microbiology Respiratory tract infections business.industry General Medicine Middle Aged Dietary Fats Anti-Bacterial Agents Bioavailability Infectious Diseases Area Under Curve Macrolides business medicine.drug |
| Zdroj: | Scandinavian Journal of Infectious Diseases. 34:823-826 |
| ISSN: | 1651-1980 0036-5548 |
| DOI: | 10.1080/0036554021000026958 |
| Popis: | Telithromycin is an innovative antibacterial designed for the treatment of community-acquired respiratory tract infections. This study assessed the effect of food on the bioavailability of a single oral dose of telithromycin 800 mg in healthy male subjects. Male volunteers aged 18-45 y were recruited for an open-label, single-dose, 2-period, cross-over study. In each trial period, subjects received a single oral dose of telithromycin 800 mg after an overnight fast, or after a standard high-fat breakfast. A washout period of 6-8 d separated the 2 study periods. All 18 subjects recruited (mean age 30.7 y) completed the study. Telithromycin was rapidly absorbed, reaching maximum plasma concentrations within a median of 2.50 and 2.25 h in the fasting and non-fasting states, respectively. There was no statistical difference between the non-fasting and fasting states for any of the pharmacokinetic parameters measured. The mean plasma telithromycin concentration versus time profiles for the non-fasting and fasting phases were almost superimposable. For the maximum plasma concentration and area under the curve from time 0 to infinity, the 90% confidence intervals for the mean non-fasting:fasting ratios were 83-116 and 101-123 mg x h/l, respectively; these are within 80-125% of the bioequivalence range. Telithromycin was well tolerated. The bioavailability, rate and extent of absorption of the new ketolide antibacterial telithromycin were unaffected by food. |
| Databáze: | OpenAIRE |
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