Effect of a high-fat meal on the pharmacokinetics of the des-F(6)-quinolone BMS-284756.
Pharmacotherapy
; 22(2): 160-5, 2002 Feb.
Article
em En
| MEDLINE
| ID: mdl-11837554
ABSTRACT
STUDY OBJECTIVE:
To evaluate the effects of a high-fat meal on the systemic exposure of oral BMS-284756.DESIGN:
Open-label, randomized, two-way crossover study.SETTING:
Clinical research facility.SUBJECTS:
Fourteen healthy individuals.INTERVENTIONS:
Participants received two single 400-mg doses of BMS-284756, separated by at least 1 week. One dose was given while participants were fasting, and one dose was given within 5 minutes of consumption of a high-fat meal. MEASUREMENTS AND MAINRESULTS:
Serial blood samples were collected, and plasma samples were analyzed for BMS-284756 using a validated liquid chromatography with tandem mass spectrometry detection method. Maximum plasma concentration and area under the plasma concentration-time curve (AUC) after the high-fat meal were 19% and 11% lower, respectively, than those in the fasted state. The 90% confidence intervals for the ratios of means (0.71-0.94 and 0.85-0.93, respectively) satisfied predefined equivalence criteria. Equivalence of the AUC values for BMS-284756 in fed and fasted individuals indicates that the presence of food should not affect the efficacy of this drug.CONCLUSION:
Single doses of BMS-284756 were safe and well tolerated and may be taken without regard to meals.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2002
Tipo de documento:
Article