Superior Silybin Bioavailability in Healthy Volunteers

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.

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Key information

Conditions

Liver Diseases Chronic Liver Disease Digestive System Diseases Fibrosis Liver Cirrhosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sylimarin and Sylibin

Other

We compared the plasma levels of Silibinin after a dosage of Silibinin-phosphatidylcholine complex, equivalent to 45 mg Silybin oily-medium soft-gel capsules after the conventional 70-mg Silymarin tablets, in 23 healthy volunteers

Primary outcomes

Time of the Bioavailability of the Silibinin vs Sylimarin

Time frame: One week

Analysis of the Bioavailability

Sponsors and collaborators

Lead sponsor

Medica Sur Clinic & Foundation

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Feb 22, 2018
Registry last updated: Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed