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- Title
Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects.
- Authors
Kasichayanula, S.; Liu, X.; Zhang, W.; Pfister, M.; Reele, S. B.; Aubry, A.-F.; LaCreta, F. P.; Boulton, D. W.
- Abstract
Dapagliflozin is a potent and selective inhibitor of sodium-glucose co-transporter type 2 that is being developed for the treatment of type 2 diabetes mellitus. This open-label, randomized, two-period, two-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 (C) by 31%, increased the time to C ( T) by 1 h, but did not affect overall dapagliflozin systemic exposure [area under the plasma concentration-time curve (AUC)]. As the cumulative (daily) amount of glucose excreted in the urine induced by dapagliflozin is dependent upon dapagliflozin AUC, the effect of food on dapagliflozin C is unlikely to have a clinically meaningful effect on dapagliflozin's efficacy. On the basis of these findings, dapagliflozin can be administered without regard to meals.
- Subjects
TYPE 2 diabetes treatment; PHARMACOKINETICS; DIET; GLUCOSE; URINE
- Publication
Diabetes, Obesity & Metabolism, 2011, Vol 13, Issue 8, p770
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/j.1463-1326.2011.01397.x