Superior Silybin Bioavailability in Healthy Volunteers

M

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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