Pharmacokinetics, Safety and Tolerability of Melissa officinalis Extract which Contained Rosmarinic Acid in Healthy Individuals: A Randomized Controlled Trial
作者： Moeko Noguchi-Shinohara , Kenjiro Ono , Tsuyoshi Hamaguchi , Kazuo Iwasa , Toshitada Nagai
DOI: 10.1371/JOURNAL.PONE.0126422
关键词: Absorption (skin) 、 Adverse effect 、 Area under the curve 、 Drug metabolism 、 Pharmacokinetics 、 Rosmarinic acid 、 Biology 、 Pharmacology 、 Randomized controlled trial 、 Tolerability
摘要: The aim of this study was to evaluate the safety, tolerability and pharmacokinetics single dose Melissa officinalis extract which contained rosmarinic acid, including food-effects in healthy individuals. A total eleven individuals were randomly assigned treatment arms two studies [Study 1 (fasted state) Study 2 (fed state)]. Rosmarinic acid serum measured by a coulometric detection method using High-Performance Liquid Chromatography electrochemical detector. concentration peaked at hour after administration containing 500mg fasted state, with maximum 162.20 nmol/ L. area under curve for intact calculated from concentration-time profile be 832.13 nmol • hour/ Food intake increases delayed time concentration. supplementation did not affect liver, kidney, or blood cell function parameters. No adverse event reported any participants due treatment. Single 500 mg appears safe tolerable increased exposure absorption individuals. Trial Registration Trial Registration: UMIN-CTR UMIN000004997
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