Lack of bioequivalence when levofloxacin and calcium-fortified orange juice are coadministered to healthy volunteers

Journal of Clinical Pharmacology

Volumn 43, Issue 5, 2003, Pages 539-544

  Wallace, Allison W ^b   Victory, Jennifer M ^b   Amsden, Guy W ^a  

^a BASSETT RESEARCH INSTITUTE   (United States)

^b NONE

Author keywords

Bioavailability effect; Calcium fortified orange juice; Drug food and drug nutrient interactions; Levofloxacin

Indexed keywords

CALCIUM; CIPROFLOXACIN; GLYCOPROTEIN P; LEVOFLOXACIN; ORGANIC ANION TRANSPORTER;

ABDOMINAL PAIN; ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHELATION; COMPETITIVE INHIBITION; CONTROLLED STUDY; DIET SUPPLEMENTATION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG ELIMINATION; FEMALE; FLATULENCE; FOOD DRUG INTERACTION; HEADACHE; HUMAN; HUMAN EXPERIMENT; INTESTINE ABSORPTION; MALE; NAUSEA; NORMAL HUMAN; ORANGE JUICE; TASTE DISORDER;

EID: 0348112532     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270003253399     Document Type: Article

References (14)

1. Wallace AW, Amsden GW: Is it really OK to take this with food? Old interactions with a new twist. J Clin Pharmacol 2002;42:437-443.
2. Food and Drug Administration: Food-Effect Bioavailability and Fed Bioequivalence Studies: Study Design, Data Analysis, and Labeling. Draft Guidance for Industry. Bethesda, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2001.
3. Neuhofel AL, Wilton JH, Victory JM, Hejmanowski LG, Amsden GW: Lack of bioequivalence of ciprofloxacin when administered with calcium-fortified orange juice: a new twist on an old interaction. J Clin Pharmacol 2002;42:461-466.
4. Polk R: Optimal use of modern antibiotics: emerging trends. Clin Infect Dis 1999;29:264-274.
5. Nix DE, Watson WA, Lener ME, Frost RW, Krol G, Goldstein H, et al: Effects of aluminum and magnesium antacids and ranitidine on the absorption of ciprofloxacin. Clin Pharmacol Ther 1989;46:700-705.
6. Cruz MSR, Alonso IG, Sanchez-Navarro A, Marinero MLS: In vitro study of the interaction between quinolones and polyvalent cations. Pharm Acta Helv 1999;73:237-245.
7. Dresser GK, Bailey DG, Leake BF, Schwarz UI, Dawson PA, Freeman DJ, Kim RB: Fruit juices inhibit organic anion transporting polypeptide-mediated drug uptake to decrease the oral availability of fexofenadine. Clin Pharmacol Ther 2002;71:11-20.
8. Takanaga H, Ohnishi A, Yamada S, Matsuo H, Morimoto S, Shoyama Y, et al: Polymetholxylated flavones in orange juice are inhibitors of P-glycoprotein by not cytochrome P450 3A4. J Pharmacol Exper Ther 2000;293:230-236.
9. Yamaguchi H, Yano I, Saito H, Inui K-I: Pharmacokinetic role of P-glycoprotein in oral bioavailability and intestinal secretion of grepafloxacin in vivo. J Pharmacol Exper Ther 2002;300:1063-1069.
10. 1. J Pharmacol Exper Ther 1997;282:955-960.
11. Yamaguchi H, Yano I, Hashimoto Y, Inui K-I: Secretory mechanisms of grepafloxacin and levofloxacin in the human intestinal cell line Caco-2. J Pharmacol Exper Ther 2000;295:360-366.
12. Cormet-Boyaka E, Huneau J-F, Mordrelle A, Boyaka PN, Carbon C, Rubinstein E, et al: Secretion of sparfloxacin from the human intestinal Caco-2 cell line is altered by P-glycoprotein inhibitors. Antimicrob Agents Chemother 1998;42:2607-2611.
13. Tamai I, Yamashita J, Kido Y, Ohnari A, Sai Y, Shima Y, et al: Limited distribution of new quinolone antibacterial agents into brain caused by multiple efflux transporters at the blood-brain barrier. J Pharmacol Exper Ther 2000;295:146-152.
14. Preston SL, Drusano GL, Berman AL, Fowler CL, Chow AT, Dornseif B, et al: Pharmacodynamics of levofloxacin: a new paradigm for early clinical trials. JAMA 1998;279:125-129.