期刊
INTERNATIONAL JOURNAL FOR VITAMIN AND NUTRITION RESEARCH
卷 74, 期 4, 页码 269-278出版社
VERLAG HANS HUBER
DOI: 10.1024/0300-9831.74.4.269
关键词
green tea; catechins; epigallocatechin gallate; EGCG; healthy volunteers; human-kinetic; pharmacokinetics; repeated dosing
This randomized, double-blind. placebo-controlled study assessed the safety, tolerability, and plasma-kinetic behaviour of 94% pure crystalline epigallocatechin gallate (EGCG) after ten days' repeated dosing in 36 healthy male volunteers. Each of the three treatment groups consisted of 12 subjects; nine of them received oral EGCG in one dose of 200. 400, or 800 mg daily, and three received a placebo. Blood samples for plasma-kinetic EGCG characterization were taken on day 1 and day 10. Kinetic parameters for rate and extent, elimination half-lives, and accumulation factor (R) were determined and compared between day 1 and day 10 for each dosage group. Orally administered EGCG is rapidly absorbed from the gut. Dose linearity was applied for single-dose application (day 1). After repeated dosing (day 10) dose linearity was applied between the 200 mg and 400 mg group. Dose escalation to 800 mg was more than dose-proportional in rate and extent, and statistically different from the 200 mg and 400 mg group. An increase in elimination half-life (t(1/2.z)) and in the accumulation factor (R) in the 800 mg dosage group indicates dose-dependent saturation of capacity-limited excretion routes or an increase of hepato-duodenal re-circulation. Ten days' repeated administration of oral doses of EGCG of up to 800 mg, per day were found to be safe and very well tolerated.
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