Document Detail


Effect of food on the pharmacokinetics of rifalazil, a novel antibacterial, in healthy male volunteers.
MedLine Citation:
PMID:  17463218     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Rifalazil is a new antibiotic structurally related to rifampin but devoid of the metabolic liabilities typically associated with the rifamycin class of antibiotics. A randomized, 3-way crossover study in healthy male volunteers (n = 12) investigated the safety and pharmacokinetics of a single 25-mg oral rifalazil dose administered under a standard breakfast containing fat as 30% of calories, a high-fat breakfast containing fat as 60% of calories, and an overnight fast of 10 hours with a 21- to 28-day washout between doses. Systemic exposure to rifalazil based on Cmax, AUC(0-Tlast), and AUC(0-infinity) was increased progressively as the fat content of the test breakfast was increased from 30% to 60% compared with fasting. The confidence intervals for both fat-containing breakfasts are outside the limits of 80% to 125% allowed for food effect bioequivalence based on Cmax, AUC(0-Tlast), and AUC(0-infinity). This food effect may be a result of increased fractional absorption with increasing dietary fat content. Another striking finding was the large reduction of the pharmacokinetic intersubject variability after rifalazil administration with food. Rifalazil was safe and well tolerated under fed and fasted conditions.
Authors:
Y-X Chen; B Cabana; N Kivel; A Michaelis
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial     Date:  2007-04-26
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  47     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-06-22     Completed Date:  2007-08-20     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  841-9     Citation Subset:  IM    
Affiliation:
ActivBiotics, Inc, Lexington, MA, USA.Ying.Chen@MPI.com
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Anti-Bacterial Agents / administration & dosage,  adverse effects*,  blood,  pharmacokinetics*
Area Under Curve
Biological Availability
Chromatography, High Pressure Liquid
Cross-Over Studies
DNA-Directed DNA Polymerase / antagonists & inhibitors
Dietary Fats
Fasting
Food
Food-Drug Interactions*
Gastric Emptying
Humans
Male
Mass Spectrometry
Middle Aged
Rifamycins / administration & dosage,  adverse effects*,  blood,  pharmacokinetics*
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Dietary Fats; 0/Rifamycins; 129791-92-0/KRM 1648; EC 2.7.7.7/DNA-Directed DNA Polymerase

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