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

David R. Foster, Kevin M. Sowinski, Hsiao-Hui Chow, Brian R. Overholser

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

The objective of this study was to develop an efficient sampling strategy to predict epigallocatechin gallate (EGCG) pharmacokinetics after green tea administration. Ten healthy subjects received a single 800-mg oral dose of EGCG administered as Polyphenon E under both fasting and fed conditions. Plasma samples were serially collected over 24 hours and EGCG concentrations were determined. A one-compartment model with a lag time for absorption best fit the concentration-time data. Maximum A Posteriori Bayesian (MAPB) priors were developed by simultaneously fitting pharmacokinetic parameters from both study phases. The D-optimal sampling designs were determined and Monte Carlo simulations were performed. The original model with the estimators was used to fit the simulated data with the optimized sampling schemes. Two and three optimal sampling strategies (OSS-2 and OSS-3, respectively) were developed. The median two sampling times for OSS-2 were 1.3 and 6.9 hours (fasting conditions) and 3.4 and 8.7 hours (fed conditions). The median three sampling times for OSS-3 were 0.7, 1.4, and 7.0 hours (fasting conditions) and 1.4, 3.6, and 8.7 hours (fed conditions). The predictive power of OSS-3 was greater than that of OSS-2, under both fasted and fed conditions, and both strategies had greater predictive performance under fasting conditions. The sampling schemes were accurate and precise in predicting EGCG oral clearance (or area under the curve with known doses), and hence exposure, under both fasting and fed conditions. The increased predictive performance for estimating pharmacokinetic parameters under fasting conditions appeared to be the result of a decreased variability in absorption.

Original languageEnglish (US)
Pages (from-to)835-842
Number of pages8
JournalTherapeutic Drug Monitoring
Volume29
Issue number6
DOIs
StatePublished - Dec 2007

Fingerprint

Polyphenols
Tea
Fasting
Sampling
Pharmacokinetics
Area Under Curve
epigallocatechin gallate
Healthy Volunteers
Plasmas

Keywords

  • Epigallocatechin gallate
  • Optimal sampling
  • Pharmacokinetics

ASJC Scopus subject areas

  • Toxicology
  • Health, Toxicology and Mutagenesis
  • Pharmacology
  • Biochemistry
  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology (medical)
  • Public Health, Environmental and Occupational Health

Cite this

Limited sampling strategies to estimate exposure to the green tea polyphenol, epigallocatechin gallate, in fasting and fed conditions. / Foster, David R.; Sowinski, Kevin M.; Chow, Hsiao-Hui; Overholser, Brian R.

In: Therapeutic Drug Monitoring, Vol. 29, No. 6, 12.2007, p. 835-842.

Research output: Contribution to journalArticle

@article{64d5837f2323404186a2ed95b26ba9a4,
title = "Limited sampling strategies to estimate exposure to the green tea polyphenol, epigallocatechin gallate, in fasting and fed conditions",
abstract = "The objective of this study was to develop an efficient sampling strategy to predict epigallocatechin gallate (EGCG) pharmacokinetics after green tea administration. Ten healthy subjects received a single 800-mg oral dose of EGCG administered as Polyphenon E under both fasting and fed conditions. Plasma samples were serially collected over 24 hours and EGCG concentrations were determined. A one-compartment model with a lag time for absorption best fit the concentration-time data. Maximum A Posteriori Bayesian (MAPB) priors were developed by simultaneously fitting pharmacokinetic parameters from both study phases. The D-optimal sampling designs were determined and Monte Carlo simulations were performed. The original model with the estimators was used to fit the simulated data with the optimized sampling schemes. Two and three optimal sampling strategies (OSS-2 and OSS-3, respectively) were developed. The median two sampling times for OSS-2 were 1.3 and 6.9 hours (fasting conditions) and 3.4 and 8.7 hours (fed conditions). The median three sampling times for OSS-3 were 0.7, 1.4, and 7.0 hours (fasting conditions) and 1.4, 3.6, and 8.7 hours (fed conditions). The predictive power of OSS-3 was greater than that of OSS-2, under both fasted and fed conditions, and both strategies had greater predictive performance under fasting conditions. The sampling schemes were accurate and precise in predicting EGCG oral clearance (or area under the curve with known doses), and hence exposure, under both fasting and fed conditions. The increased predictive performance for estimating pharmacokinetic parameters under fasting conditions appeared to be the result of a decreased variability in absorption.",
keywords = "Epigallocatechin gallate, Optimal sampling, Pharmacokinetics",
author = "Foster, {David R.} and Sowinski, {Kevin M.} and Hsiao-Hui Chow and Overholser, {Brian R.}",
year = "2007",
month = "12",
doi = "10.1097/FTD.0b013e31815bf58b",
language = "English (US)",
volume = "29",
pages = "835--842",
journal = "Therapeutic Drug Monitoring",
issn = "0163-4356",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

TY - JOUR

T1 - Limited sampling strategies to estimate exposure to the green tea polyphenol, epigallocatechin gallate, in fasting and fed conditions

AU - Foster, David R.

AU - Sowinski, Kevin M.

AU - Chow, Hsiao-Hui

AU - Overholser, Brian R.

PY - 2007/12

Y1 - 2007/12

N2 - The objective of this study was to develop an efficient sampling strategy to predict epigallocatechin gallate (EGCG) pharmacokinetics after green tea administration. Ten healthy subjects received a single 800-mg oral dose of EGCG administered as Polyphenon E under both fasting and fed conditions. Plasma samples were serially collected over 24 hours and EGCG concentrations were determined. A one-compartment model with a lag time for absorption best fit the concentration-time data. Maximum A Posteriori Bayesian (MAPB) priors were developed by simultaneously fitting pharmacokinetic parameters from both study phases. The D-optimal sampling designs were determined and Monte Carlo simulations were performed. The original model with the estimators was used to fit the simulated data with the optimized sampling schemes. Two and three optimal sampling strategies (OSS-2 and OSS-3, respectively) were developed. The median two sampling times for OSS-2 were 1.3 and 6.9 hours (fasting conditions) and 3.4 and 8.7 hours (fed conditions). The median three sampling times for OSS-3 were 0.7, 1.4, and 7.0 hours (fasting conditions) and 1.4, 3.6, and 8.7 hours (fed conditions). The predictive power of OSS-3 was greater than that of OSS-2, under both fasted and fed conditions, and both strategies had greater predictive performance under fasting conditions. The sampling schemes were accurate and precise in predicting EGCG oral clearance (or area under the curve with known doses), and hence exposure, under both fasting and fed conditions. The increased predictive performance for estimating pharmacokinetic parameters under fasting conditions appeared to be the result of a decreased variability in absorption.

AB - The objective of this study was to develop an efficient sampling strategy to predict epigallocatechin gallate (EGCG) pharmacokinetics after green tea administration. Ten healthy subjects received a single 800-mg oral dose of EGCG administered as Polyphenon E under both fasting and fed conditions. Plasma samples were serially collected over 24 hours and EGCG concentrations were determined. A one-compartment model with a lag time for absorption best fit the concentration-time data. Maximum A Posteriori Bayesian (MAPB) priors were developed by simultaneously fitting pharmacokinetic parameters from both study phases. The D-optimal sampling designs were determined and Monte Carlo simulations were performed. The original model with the estimators was used to fit the simulated data with the optimized sampling schemes. Two and three optimal sampling strategies (OSS-2 and OSS-3, respectively) were developed. The median two sampling times for OSS-2 were 1.3 and 6.9 hours (fasting conditions) and 3.4 and 8.7 hours (fed conditions). The median three sampling times for OSS-3 were 0.7, 1.4, and 7.0 hours (fasting conditions) and 1.4, 3.6, and 8.7 hours (fed conditions). The predictive power of OSS-3 was greater than that of OSS-2, under both fasted and fed conditions, and both strategies had greater predictive performance under fasting conditions. The sampling schemes were accurate and precise in predicting EGCG oral clearance (or area under the curve with known doses), and hence exposure, under both fasting and fed conditions. The increased predictive performance for estimating pharmacokinetic parameters under fasting conditions appeared to be the result of a decreased variability in absorption.

KW - Epigallocatechin gallate

KW - Optimal sampling

KW - Pharmacokinetics

UR - http://www.scopus.com/inward/record.url?scp=36549064848&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=36549064848&partnerID=8YFLogxK

U2 - 10.1097/FTD.0b013e31815bf58b

DO - 10.1097/FTD.0b013e31815bf58b

M3 - Article

C2 - 18043484

AN - SCOPUS:36549064848

VL - 29

SP - 835

EP - 842

JO - Therapeutic Drug Monitoring

JF - Therapeutic Drug Monitoring

SN - 0163-4356

IS - 6

ER -