期刊
DIABETES OBESITY & METABOLISM
卷 13, 期 8, 页码 770-773出版社
WILEY
DOI: 10.1111/j.1463-1326.2011.01397.x
关键词
dapagliflozin; diabetes mellitus; fat; food effect; high-fat meal; inhibitors; pharmacodynamics; pharmacokinetics; SGLT2
资金
- Bristol-Myers Squibb Company
- AstraZeneca
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-max) by 31%, increased the time to C-max (T-max) 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 Cmax 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.
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