CLINICAL TRIAL: PHASE I STUDY OF SILYMARIN IN CHRONIC HEPATITIS C OR FATTY LIVER

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项1期研究旨在评估口服水飞蓟素治疗慢性丙型肝炎和非酒精性脂肪性肝病患者的安全性、耐受性和药代动力学。主要目标是确定非肝硬化性肝病患者的水飞蓟素暴露水平是安全的，并确定暴露是否与剂量成比例，以及确定在丙型肝炎或非酒精性脂肪肝患者口服单剂量和多剂量Legalon后，六种主要水飞蓟素异构体的药代动力学。第二个目标是确定在丙型肝炎患者单次服用280毫克的Legalon剂量后，典型的800大卡美国餐对水飞蓟素六种主要异构体的相对口服生物利用度的影响。这是一项多中心、随机、双盲、安慰剂对照、平行分组的剂量递增研究，包括一个交叉研究臂，旨在评估高卡路里膳食对利卡隆的生物利用度的影响。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This phase 1 study is designed to evaluate the safety, tolerability and pharmacokinetics of orally administered silymarin in non-cirrhotic subjects with chronic hepatitis C and non-alcoholic fatty liver disease. The primary objective is to identify silymarin exposure levels in patients with non-cirrhotic liver disease that are safe and to determine if exposures are dose-proportional, as well as to determine the pharmacokinetics for the six principal silymarin isomers, after single and multiple doses of Legalon administered orally up to 700 mg three times daily in patients with either HCV or NAFLD. The secondary objectives are to determine the effect of a typical 800 kcal American meal on the relative oral bioavailability of the six principal isomers of silymarin following a single Legalon dose of 280 mg in patients with HCV. This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-escalation study that includes a crossover study arm designed to evaluate the effect of a high calorie meal on the bioavailability of Legalon.