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Superior Silybin Bioavailability in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03440164
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Nahum Méndez-Sánchez, Medica Sur Clinic & Foundation

Study Description
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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
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
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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 : November 11, 2016
Actual Primary Completion Date : December 8, 2016
Actual Study Completion Date : December 15, 2016
Groups and Cohorts
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Intervention Details:
  • Other: Sylimarin and Sylibin
    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

Outcome Measures
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Primary Outcome Measures :
  1. Time of the Bioavailability of the Silibinin vs Sylimarin [ Time Frame: One week ]
    Analysis of the Bioavailability


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All healthy volunteers
Criteria

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
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nahum Méndez-Sánchez, Gastroenterologist and Hepatologist, Medica Sur Clinic & Foundation
ClinicalTrials.gov Identifier: NCT03440164    
Other Study ID Numbers: CONBIOETICA14CEI02820131108
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Our results will be published in a scientific journal
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: From 2017 to date
Access Criteria: Publication in Open Acess

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nahum Méndez-Sánchez, Medica Sur Clinic & Foundation:
liver fibrosis
Hepatoprotective
Sylimarin
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases