Superior Silybin Bioavailability in Healthy Volunteers

Sponsor

Medica Sur Clinic & Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT03440164

Collaborator

(none)

Enrollment

1.1

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Chronic Liver Disease	Other: Sylimarin and Sylibin

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

24 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 11, 2016

Actual Primary Completion Date :

Dec 8, 2016

Actual Study Completion Date :

Dec 15, 2016

Outcome Measures

Primary Outcome Measures

Time of the Bioavailability of the Silibinin vs Sylimarin [One week]
Analysis of the Bioavailability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medica Sur Clinic & Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nahum Méndez-Sánchez, Gastroenterologist and Hepatologist, Medica Sur Clinic & Foundation

ClinicalTrials.gov Identifier:

NCT03440164

Other Study ID Numbers:

CONBIOETICA14CEI02820131108

First Posted:

Feb 22, 2018

Last Update Posted:

Feb 22, 2018

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nahum Méndez-Sánchez, Gastroenterologist and Hepatologist, Medica Sur Clinic & Foundation

liver fibrosis

Hepatoprotective

Sylimarin

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Feb 22, 2018