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Effect of a High‐Fat Meal on the Pharmacokinetics of the Des‐F(6)‐Quinolone BMS‐284756
Author(s) -
Gajjar Diptee A.,
Sukoneck Samuel C.,
Bello Akintunde,
Ge Zhiyu,
Christopher Lisa,
Grasela Dennis M.
Publication year - 2002
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.22.3.160.33556
Subject(s) - meal , pharmacokinetics , crossover study , confidence interval , medicine , plasma concentration , zoology , pharmacology , alternative medicine , pathology , placebo , biology
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 Main Results. 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.