Effect of food or antacid on pharmacokinetics and pharmacodynamics of febuxostat in healthy subjects

British Journal of Clinical Pharmacology

Volumn 65, Issue 3, 2008, Pages 355-363

  Khosravan, Reza ^a,b,d   Grabowski, Brian ^a   Wu, Jing Tao ^a   Joseph Ridge, Nancy ^a   Vernillet, Laurent ^a,c  

^a TAP Pharmaceuticals   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^c GENENTECH INC   (United States)

^d PFIZER INC   (United States)

Author keywords

Antacid; Febuxostat; Food; Pharmacodynamics; Pharmacokinetics; Uric acid

Indexed keywords

ALUMINUM MAGNESIUM HYDROXIDE; FEBUXOSTAT; URIC ACID;

ABDOMINAL CRAMP; ADULT; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFECT; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOOD; FOOD DRUG INTERACTION; HEADACHE; HUMAN; HUMAN EXPERIMENT; MALE; MONOTHERAPY; MYALGIA; NAUSEA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; URIC ACID BLOOD LEVEL;

ADULT; ANTACIDS; CROSS-OVER STUDIES; DIETARY FATS; DRUG INTERACTIONS; FASTING; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; THIAZOLES;

EID: 39849107900     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2007.03016.x     Document Type: Article

References (25)

1. Palella TD, Fox IH. Hyperuricemia and gout. In : The Metabolic Basis of Inherited Disease, 6th edn, Scriver CR, Beaudet AL, Sly WS, Valle D. New York : McGraw-Hill 2003.
2. Roubenoff R. Gout and hyperuricemia. Rheum Dis Clin North Am 1990 16 : 539 50.
3. Roubenoff R, Klag MJ, Mead LA, Liang KY, Seidler AJ, Hochberg MC. Incidence and risk factors for gout in white men. JAMA 1991 266 : 3004 7.
4. Takano Y, Hase-Aoki K, Horiuchi H, Zhao L, Kasahara Y, Kondo S, Becker MA. Selectivity of febuxostat, a novel non-purine inhibitor of xanthine oxidase/xanthine dehydrogenase. Life Sci 2005 76 : 1835 47.
5. Becker MA, Schumacher HR Jr., Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, Phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum 2005 52 : 916 23.
6. Becker MA, Schumacher HR, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005 353 : 2450 61.
7. Grabowski BA, Vernillet L, Khosravan R, Wu JT, Joseph-Ridge N, Mulford DJ. Metabolism and excretion of [14C] febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, in healthy male subjects. Drug Metab Rev 2005 37 (Supp. 2 111.
8. Khosravan R, Grabowski BA, Mayer MD, Wu JT, Joseph-Ridge N, Vernillet L. The effect of mild and moderate hepatic impairment on pharmacokinetics, pharmacodynamics, and safety of febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase. J Clin Pharmacol 2006 46 : 88 102.
9. Mayer MD, Khosravan R, Vernillet L, Wu JT, Joseph-Ridge N, Mulford DJ. Pharmacokinetics and pharmacodynamics of febuxostat, a new non-purine selective inhibitor of xanthine oxidase in subjects with renal impairment. Am J Ther 2005 12 : 22 34.
10. Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995 12 : 413 20.
11. Fleisher D, Li C, Zhou Y, Pao LH, Karim A. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications. Clin Pharmacokinet 1999 36 : 233 54.
12. Lin HC, Doty JE, Reedy TJ, Meyer JH. Inhibition of gastric emptying by glucose depends on length of intestine exposed to nutrient. Am J Physiol 1989 256 (2 Part 1 G404 11.
13. Lin HC, Kim BH, Elashoff JD, Doty JE, Gu YG, Meyer JH. Gastric emptying of solid food is most potently inhibited by carbohydrate in the canine distal ileum. Gastroenterology 1992 102 : 793 801.
14. Carver PL, Fleisher D, Zhou SY, Kaul D, Kazanjian P, Li C. Meal composition effects on the oral bioavailability of indinavir in HIV-infected patients. Pharm Res 1999 16 : 718 24.
15. Tschanz C, Stargel WW, Thomas JA. Interactions between drugs and nutrients. Adv Pharmacol 1996 35 : 1 26.
16. Collins PJ, Horowitz M, Maddox A, Myers JC, Chatterton BE. Effects of increasing solid component size of a mixed solid/liquid meal on solid and liquid gastric emptying. Am J Physiol 1996 271 (4 Part 1 G549 54.
17. Miles C, Dickson P, Rana K, Lippert C, Fleisher D. CCK antagonist pre-treatment inhibits meal-enhanced drug absorption in dogs. Regul Pept 1997 68 : 9 14.
18. Williams L, Hill DP Jr., Davis JA, Lowenthal DT. The influence of food on the absorption and metabolism of drugs: an update. Eur J Drug Metab Pharmacokinet 1996 21 : 201 11.
19. Lomaestro BM, Bailie GR. Absorption interactions with fluoroquinolones. 1995 update. Drug Saf 1995 12 : 314 33.
20. Pao LH, Zhou SY, Cook C, Kararli T, Kirchhoff C, Truelove J, Karim A, Fleisher D. Reduced systemic availability of an antiarrhythmic drug, bidisomide, with meal co-administration: relationship with region-dependent intestinal absorption. Pharm Res 1998 15 : 221 7.
21. McCrindle JL, Li Kam Wa TC, Barron W, Prescott LF. Effect of food on the absorption of frusemide and bumetanide in man. Br J Clin Pharmacol 1996 42 : 743 6.
22. Mizuta H, Kawazoe Y, Ogawa K. Gastrointestinal absorption of chlorothiazide: evaluation of a method using salicylazosulfapyridine and acetaminophen as the marker compounds for determination of the gastrointestinal transit time in the dog. Chem Pharm Bull (Tokyo) 1990 38 : 2810 3.
23. Maton PN, Burton ME. Antacids revisited: a review of their clinical pharmacology and recommended therapeutic use. Drugs 1999 57 : 855 70.
24. Yamamoto T, Moriwaki Y, Takahashi S, Tsutsumi Z, Ohata H, Yamakita J, Nakamo T, Higashino K. Effect of amino acids on the plasma concentration and urinary excretion of uric acid and uridine. Metabolism 1999 48 : 1023 7.
25. Khosravan R, Grabowski BA, Wu JT, Joseph-Ridge N, Vernillet L. Effect of food or antacid on febuxostat pharmacokinetics and pharmacodynamics in healthy subjects. Clin Pharmacol Ther 2005 77 : 50 [Abstract].