The bioavailability of oral fludarabine phosphate is unaffected by food

The Hematology Journal : the Official Journal of the European Haematology Association
D OscierH Gieschen

Abstract

A prospective, open and randomized, two-way crossover study was conducted to evaluate the pharmacokinetics and bioavailability of oral fludarabine phosphate when taken on a full versus an empty stomach. The effectiveness of therapy was also assessed after two cycles of treatment, four weeks apart Patients with chronic lymphocytic leukemia or low-grade non-Hodgkin's lymphoma were randomly assigned to two groups, both of which received two cycles of treatment with 90 mg of oral fludarabine phosphate administered when either fed or fasted. Patients in Group 1 (n = 8) received oral treatment on a full stomach for the first cycle then on a fasted stomach for the second, while those in Group 2 (n = 10) received their treatment in the reverse sequence. Oral fludarabine phosphate was administered on the first day of the two study cycles and intravenous fludarabine phosphate was administered on days 3-6. Of 22 patients recruited, 18 (CLL n = 10; NHL n = 8) were eligible for efficacy and safety evaluation, and 16 for bioavailability and pharmacokinetic analyses. The response to oral 2-F-ara-AMP was rapid: by two treatment cycles, 12 out of 18 patients (66.7%) had achieved partial response. Of the six patients who did not respond, five pa...Continue Reading

Citations

Jan 8, 2010·Drug Design, Development and Therapy·Ann JanssensGregor Verhoef
May 8, 2008·Expert Review of Ophthalmology·Xiaoyan DingChi-Chao Chan
Oct 29, 2009·Biopharmaceutics & Drug Disposition·Wei YinJohn Lister-James
Mar 31, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J-F RossiS M Tollerfield
Apr 12, 2003·Leukemia & Lymphoma·Tadeusz Robak
Jun 21, 2013·Expert Review of Hematology·Laetitia Souchet-CompainVéronique Leblond
Oct 6, 2006·Expert Review of Anticancer Therapy·Marco MontilloAlessandra Tedeschi
Nov 9, 2005·Annals of Oncology : Official Journal of the European Society for Medical Oncology·Y OgawaT Seriu

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