CClinicalTrials.gg
CompletedNCT03440164Updated Feb 22, 2018

Superior Silybin Bioavailability in Healthy Volunteers

An observational study in Liver Diseases and Chronic Liver Disease, sponsored by Medica Sur Clinic & Foundation. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Medica Sur Clinic & Foundation · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
24
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Liver Diseases
  • Chronic Liver Disease

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Keywords

  • liver fibrosis
  • Hepatoprotective
  • Sylimarin
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All 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

Exclusion Criteria:

  • Subject with HIV, HBV, HCV
  • Subject with comorbidities
  • Subject less 18 years old Subject higher 50 years old
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
24 participants (actual)
Patient registry
No

Interventions

  • OtherSylimarin 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

05

What researchers measure

Primary outcomes

  1. Time of the Bioavailability of the Silibinin vs Sylimarin

    Analysis of the Bioavailability

    Time frame: One week

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Mendez-Sanchez N, Dibildox-Martinez M, Sosa-Noguera J, Sanchez-Medal R, Flores-Murrieta FJ. Superior silybin bioavailability of silybin-phosphatidylcholine complex in oily-medium soft-gel capsules versus conventional silymarin tablets in healthy volunteers. BMC Pharmacol Toxicol. 2019 Jan 11;20(1):5. doi: 10.1186/s40360-018-0280-8. Erratum In: BMC Pharmacol Toxicol. 2019 Feb 22;20(1):14. doi: 10.1186/s40360-019-0290-1. BMC Pharmacol Toxicol. 2021 Jun 25;22(1):37. doi: 10.1186/s40360-021-00500-2. PubMed 30635055 ↗

Individual participant data

Plan to share: Yes — Our results will be published in a scientific journal

Supporting information: Study protocol, Sap, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT03440164
Lead sponsor
Medica Sur Clinic & Foundation
Responsible party
Nahum Méndez-Sánchez (Gastroenterologist and Hepatologist, Medica Sur Clinic & Foundation) — Principal investigator
First posted
Feb 22, 2018
Start date
Nov 11, 2016
Primary completion
Dec 8, 2016
Completion
Dec 15, 2016
Last update
Feb 22, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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