Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects

Diabetes, Obesity and Metabolism

Volumn 13, Issue 8, 2011, Pages 770-773

  Kasichayanula, S ^a   Liu, X ^a   Zhang, W ^a,b   Pfister, M ^a   Reele, S B ^c   Aubry, A F ^a   Lacreta, F P ^a   Boulton, D W ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b HOFFMANN LA ROCHE INC   (United States)

^c Reele Consulting   (United States)

Author keywords

Dapagliflozin; Diabetes mellitus; Fat; Food effect; High fat meal; Inhibitors; Pharmacodynamics; Pharmacokinetics; SGLT2

Indexed keywords

DAPAGLIFLOZIN; GLUCOSE;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; CROSSOVER PROCEDURE; DRUG EFFICACY; FEMALE; FOOD INTAKE; GLUCOSE URINE LEVEL; HUMAN; HUMAN EXPERIMENT; LIPID DIET; MALE; MAXIMUM PLASMA CONCENTRATION; MEAL; NON INSULIN DEPENDENT DIABETES MELLITUS; NORMAL HUMAN; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 79959423575     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2011.01397.x     Document Type: Article

References (10)

1. Washburn WN. Evolution of sodium glucose co-transporter 2 inhibitors as anti-diabetic agents. Expert Opin Ther Pat 2009; 19: 1485-1499.
2. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 2010; 375: 2223-2233.
3. Komoroski B, Vachharajani N, Boulton D et al. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther 2009; 85: 520-526.
4. Obermeier M, Yao M, Khanna A et al. In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Drug Metab Dispos 2010; 38: 405-414.
5. Martinez MN, Amidon GL. A mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals. J Clin Pharmacol 2002; 42: 620-643.
6. Martinez M, Amidon G, Clarke L, Jones WW, Mitra A, Riviere J. Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part II. Physiological considerations. Adv Drug Deliv Rev 2002; 54: 825-850.
7. FDA. Guidance for Industry: Food Effect Bioavailability and Fed Bioequivalence Studies. Rockville, MD: U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, 2002.
8. Houghton LA, Mangnall YF, Read NW. Effect of incorporating fat into a liquid test meal on the relation between intragastric distribution and gastric emptying in human volunteers. Gut 1990; 31: 1226-1229.
9. Stacher G, Granser GV, Bergmann H, Kugi A, Stacher-Janotta G, Hobart J. Slow gastric emptying induced by high fat content of meal accelerated by cisapride administered rectally. Dig Dis Sci 1991; 36: 1259-1265.
10. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase III trial. Diabetes Care 2010; 33: 2217-2224.