Prolonged, but not diminished, zidovudine absorption induced by a high-fat breakfast.
Pharmacotherapy
; 14(6): 671-7, 1994.
Article
em En
| MEDLINE
| ID: mdl-7885970
ABSTRACT
STUDY OBJECTIVE:
To determine the effect of a high-fat breakfast on single-dose, zidovudine (ZDV) pharmacokinetics.DESIGN:
Open-label, randomized, crossover study. PATIENTS Eighteen asymptomatic subjects (12 men, 6 women) infected with the human immunodeficiency virus (mean CD4 cell counts of 512 +/- 178/mm3).INTERVENTIONS:
Subjects received single 100-mg oral doses of ZDV as follows after an 8-hour fast (treatment A), with a high-fat breakfast (treatment B), and 3 hours after a high-fat breakfast (treatment C). MEASUREMENTS AND MAINRESULTS:
The high-fat breakfast significantly reduced the mean (coefficient of variation) maximum plasma concentration (Cmax) from 806 (55%) ng/ml with treatment A to 341 (47%) and 424 (42%) ng/ml with treatments B and C, respectively. The time to Cmax was significantly prolonged from 0.68 (30%) hours with treatment A to 1.7 (54%) and 1.3 (42%) hours with treatments B and C, respectively. Area under the plasma ZDV concentration-time curve (AUC) was not statistically different across the study treatments. Men had significantly lower (35%) renal clearances of both ZDV and its glucuronide metabolite than women.CONCLUSIONS:
When ZDV was given either with or 3 hours after a high-fat breakfast, its absorption was prolonged and Cmax was reduced relative to fasting. However, systemic exposure, as indicated by AUC, was unchanged.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Gorduras na Dieta
/
Zidovudina
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Pharmacotherapy
Ano de publicação:
1994
Tipo de documento:
Article
País de publicação:
EEUU
/
ESTADOS UNIDOS
/
ESTADOS UNIDOS DA AMERICA
/
EUA
/
UNITED STATES
/
UNITED STATES OF AMERICA
/
US
/
USA