Pharmacokinetics of (-)Epicatechin 3-O-Gallate, Glycyrrhetic Acid and Rhein in Healthy Male Volunteers after Multiple Dose Administration of TJ-8117 (Unipito), a Japanese Traditional Medicine for Renal Failure
スポンサーリンク
概要
- 論文の詳細を見る
Aims: Unpito, an herbal medicine extracted from a mixture of five crude medicines (Rhei Rhizoma, Glycyrrhizae Radix, Ginseng Radix, Zingiberis Rhizoma and Aconiti Tuber), has been developed as a drug for chronic renal failure. In general, it is difficult to estimate the absorption and excretion of herbal medicines due to the presence of a wide variety of components. The purpose of the current study was to examine the systemic pharmacokinetics and elimination of Unpito in healthy volunteers following repeated administration as part of the clinical study of the medicine. Methods: Three compounds, (-) epicatechin 3-O-gallate (ECG), glycyrrhetic acid (GA) and rhein (RH) were selected as markers, to examine the clinical pharmacokinetics of Unpito based on their levels in this medicine. The disposition of each compound was evaluated in 24 healthy volunteers receiving multiple oral doses (4, 6, and 8 capsules three times a day). Results: After repeated administration, plasma ECG and GA concentrations were lower than those simulated. RH plasma concentrations were consistent with the simulation, indicating linear pharmacokinetics of RH. The potential accumulations of marker compounds were not observed from the roughly constant plasma concentrations of troughs at 72, 120, and 144 h after the first administration nor from the urinary excretions. Conclusions: This is the first study presenting pharmacokinetics of ECG, GA and RH derived from Unpito, an herbal medicine, in healthy volunteers after multiple dose administration.
- 日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeuticsの論文
- 2006-01-00
日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics | 論文
- 後発医薬品会社における個別症例安全性報告の因果関係評価基準
- 臨床試験において収集される有害事象情報の実態調査
- 臨床試験の効率化を目的とした電子カルテからe-CRFへのデータ転送の方向性
- 新GCP下の臨床試験における服薬コンプライアンスに関する調査
- 降圧薬の内服により Phenocopy 現象をきたした1例