Limited sampling strategies to estimate exposure to the green tea polyphenol, epigallocatechin gallate, in fasting and fed conditions

Therapeutic Drug Monitoring

Volumn 29, Issue 6, 2007, Pages 835-842

  Foster, David R ^a,b   Sowinski, Kevin M ^a,b   Chow, H H Sherry ^c   Overholser, Brian R ^a,b  

^a PURDUE UNIVERSITY   (United States)

^b INDIANA UNIVERSITY   (United States)

^c UNIVERSITY OF ARIZONA   (United States)

Author keywords

Epigallocatechin gallate; Optimal sampling; Pharmacokinetics

Indexed keywords

EPIGALLOCATECHIN GALLATE; POLYPHENOL; POLYPHENON E; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DATA ANALYSIS; DIET RESTRICTION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; HUMAN; HUMAN EXPERIMENT; MONTE CARLO METHOD; NORMAL HUMAN; PLASMA; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SAMPLING; SINGLE DRUG DOSE; TEA;

CAMELLIA SINENSIS; CATECHIN; CROSS-OVER STUDIES; EATING; FASTING; HUMANS; TEA; TIME FACTORS;

EID: 36549064848     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31815bf58b     Document Type: Article

References (29)

1. McKenna DJ, Hughes K, Jones K. Green tea monograph. Altern Ther Health Med. 1970;6:61-68.
2. Pisters KM, Newman RA, Coldman B, et al. Phase I trial of oral green tea extract in adult patientswith solid tumors. J Clin Oncol. 2001;19:1830-1838.
3. Jatoi A, Ellison N, Burch PA, et al. A phase II trial of green tea in the treatment of patients with androgen independent metastatic prostate carcinoma. Cancer. 2003;97:1442-1446.
4. Laurie SA, Miller VA, Grant SC, et al. Phase I study of green tea extract in patients with advanced lung cancer. Cancer Chemother Pharmacol. 2005;55:33-38.
5. Yang CS, Chen L, Lee MJ, et al. Blood and urine levels of tea catechins after ingestion of different amounts of green tea by human volunteers. Cancer Epidemiol Biomarkers Prev. 1998;7:351-354.
6. Moyers SB, Kumar NB. Green tea polyphenols and cancer chemoprevention: multiple mechanisms and endpoints for phase II trials. Nutr Rev. 2004;62:204-211.
7. Yang CS, Sang S, Lambert JD, et al. Possible mechanisms of the cancerpreventive activities of green tea. Mol Nutr Food Res. 2006;50:170-175.
8. Lee MJ, Maliakal P, Chen L, et al. Pharmacokinetics of tea catechins after ingestion of green tea and (-)-epigallocatechin-3-gallate by humans: formation of different metabolites and individual variability. Cancer Epidemiol Biomarkers Prev. 2002;11:1025-1032.
9. Yang CS, Prabhu S, Landau J. Prevention of carcinogenesis by tea polyphenols. Drug Metab Rev. 2001;33:237-253.
10. Sano M, Tabata M, Suzuki M, et al. Simultaneous determination of twelve tea catechins by high-performance liquid chromatography with electrochemical detection. Analyst. 2001;126:816-820.
11. Umegaki K, Sugisawa A, Yamada K, et al. Analytical method of measuring tea catechins in human plasma by solid-phase extraction and HPLC with electrochemical detection. J Nutr Sci Vitaminol (Tokyo). 2001;47:402-408.
12. Sloan JA, Atherton P, Reid J, et al. Limited sampling models for CPT-11, SN-38, and SN-38 glucuronide. Cancer Chemother Pharmacol. 2001;48:241-249.
13. van Warmerdam LJ, ten Bokkel Huinink WW, Maes RA, et al. Limited-sampling models for anticancer agents. J Cancer Res Clin Oncol. 1994;120:427-433.
14. Panetta JC, Iacono LC, Adamson PC, et al. The importance of pharmacokinetic limited sampling models for childhood cancer drug development. Clin Cancer Res. 2003;9:5068-5077.
15. Di PA, Danesi R, Vannozzi F, et al. Limited sampling model for the analysis of 5-fluorouracil pharmacokinetics in adjuvant chemotherapy for colorectal cancer. Clin Pharmacol Ther. 2002;72:627-637.
16. Chow HH, Hakim IA, Vining DR, et al. Effects of dosing condition on the oral bioavailability of green tea catechins after single-dose administration of Polyphenon E in healthy individuals. Clin Cancer Res. 2005;11:4627-4633.
17. Yang CS, Chen L, Lee MJ, et al. Blood and urine levels of tea catechins after ingestion of different amounts of green tea by human volunteers. Cancer Epidemiol Biomarkers Prev. 1998;7:351-354.
18. Lee MJ, Wang ZY, Li H, et al. Analysis of plasma and urinary tea polyphenols in human subjects. Cancer Epidemiol Biomarkers Prev. 1995;4:393-399.
19. D'Argenio D, Schumitzky A. ADAPT II User's Guide. Biomedical Simulations Resource. Los Angeles: University of Southern California; 1992.
20. Overholser BR, Brophy DF, Sowinski KM. Development of an efficient sampling strategy to predict enoxaparin pharmacokinetics in stage 5 chronic kidney disease. Ther Drug Monit. 2006;28:807-812.
21. Akaike H. An information criterion (AIC). Math Sci. 1976;153:5-9.
22. Roos JF, Bulitta J, Lipman J, et al. Pharmacokinetic-pharmacodynamic rationale for cefepime dosing regimens in intensive care units. J Antimicrob Chemother. 2006;58:987-993.
23. Wagner JG. Pharmacokinetics for the pharmaceutical scientist. Lancaster, PA: Technomic Publishing Co; 1993:36-40.
24. D'Argenio DZ. Optimal sampling times for pharmacokinetic experiments. J Pharmacokinet Biopharmacol. 1981;9:739-756.
25. Lambert JD, Lee MJ, Lu H, et al. Epigallocatechin-3-gallate is absorbed but extensively glucuronidated following oral administration to mice. J Nutr. 2003;133:4172-4177.
26. Chen L, Lee MJ, Li H, et al. Absorption, distribution, elimination of tea polyphenols in rats. Drug Metab Dispos. 1997;25:1045-1050.
27. Chow HH, Cai Y, Alberts DS, et al. Phase I pharmacokinetic study of tea polyphenols following single-dose administration of epigallocatechin gallate and Polyphenon E. Cancer Epidemiol Biomarkers Prev. 2001;10:53-58.
28. Ullmann U, Haller J, Decourt JD, et al. Plasma-kinetic characteristics of purified and isolated green tea catechin epigallocatechin gallate (EGCG) after 10 days repeated dosing in healthy volunteers. Int J Vitam Nutr Res. 2004;74:269-278.
29. Chow HH, Cai Y, Hakim IA, et al. Pharmacokinetics and safety of green tea polyphenols after multiple-dose administration of epigallocatechin gallate and Polyphenon E in healthy individuals. Clin Cancer Res. 2003;9:3312-3319.