| Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects. | |
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MedLine Citation:
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PMID: 21435141 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Dapagliflozin is a potent and selective inhibitor of sodium-glucose co-transporter type 2 (SGLT2) that is being developed for the treatment of type 2 diabetes mellitus. This open-label, randomized, 2-period, 2-treatment (single doses of 10 mg dapagliflozin fasted or fed), crossover study was conducted to evaluate the effect of a high fat meal on the pharmacokinetics of dapagliflozin in 14 healthy subjects. Compared to the fasted state, a high fat meal decreased mean dapagliflozin maximum plasma concentrations (Cmax) by 31%, increased the time to Cmax (Tmax) by 1 hr, but did not affect overall dapagliflozin systemic exposure (AUC). Since the cumulative (daily) amount of glucose excreted in the urine induced by dapagliflozin is dependent upon dapagliflozin AUC, the effect of food on dapagliflozin Cmax is unlikely to have a clinically meaningful effect on dapagliflozin's efficacy. Based on these findings, dapagliflozin can be administered without regards to meals. |
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Authors:
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S Kasichayanula; X Liu; W Zhang; M Pfister; S B Reele; A-F Aubry; F P Lacreta; D W Boulton |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-3-17 |
Journal Detail:
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Title: Diabetes, obesity & metabolism Volume: - ISSN: 1463-1326 ISO Abbreviation: - Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-3-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100883645 Medline TA: Diabetes Obes Metab Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2011 Blackwell Publishing Ltd. |
Affiliation:
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R&D, Bristol-Myers Squibb Company, Princeton, NJ, USA Reele Consulting, LLC, Scottville, VA, USA Hoffman La-Roche, Nutley, NJ, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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