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临床试验/NCT03440164
NCT03440164已完成不适用

Superior Bioavailability of the Silybin-Phosphatidylcholine Complex in Oily-Medium Soft-Gel Capsules Versus Conventional Silymarin Tablets in Healthy Volunteers

Medica Sur Clinic & Foundation0 个研究点目标入组 24 人开始时间: 2016年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
主要终点
Time of the Bioavailability of the Silibinin vs Sylimarin

研究概览

简要总结

Twenty-four healthy volunteers of both genders, aged 18 to 44 years old and body mass indexes between 18 to 27 kg/m2,were selected to participate in a two-way, balanced, prospective, blind, single-dose crossover study with a one-week wash-out period. It was assessed that volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis. All subjects were negative for HIV, HBV, and HCV.

详细描述

In healthy volunteers single-dose crossover study with a one week, It was assessed that volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases.
  • The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis

排除标准

  • Subject with HIV, HBV, HCV
  • Subject with comorbidities
  • Subject less 18 years old Subject higher 50 years old

结局指标

主要结局

Time of the Bioavailability of the Silibinin vs Sylimarin

时间窗: One week

Analysis of the Bioavailability

次要结局

未报告次要终点

研究者

发起方
Medica Sur Clinic & Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nahum Méndez-Sánchez

Gastroenterologist and Hepatologist

Medica Sur Clinic & Foundation

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