Superior Silybin Bioavailability in Healthy Volunteers

Medica Sur Clinic & Foundation

Status: Completed

Conditions: Chronic Liver Disease; Liver Diseases

Treatments: Other: Sylimarin and Sylibin

Study type: Observational

Funder types: Other

Identifiers

NCT03440164

CONBIOETICA14CEI02820131108

Details and patient eligibility

About

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.

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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