- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03440164
Superior Silybin Bioavailability in Healthy Volunteers
February 14, 2018 updated by: Nahum Méndez-Sánchez, Medica Sur Clinic & Foundation
Superior Bioavailability of the Silybin-Phosphatidylcholine Complex in Oily-Medium Soft-Gel Capsules Versus Conventional Silymarin Tablets in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
24
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All healthy volunteers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of the Bioavailability of the Silibinin vs Sylimarin
Time Frame: One week
|
Analysis of the Bioavailability
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2016
Primary Completion (Actual)
December 8, 2016
Study Completion (Actual)
December 15, 2016
Study Registration Dates
First Submitted
February 14, 2018
First Submitted That Met QC Criteria
February 14, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 14, 2018
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CONBIOETICA14CEI02820131108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Our results will be published in a scientific journal
IPD Sharing Time Frame
From 2017 to date
IPD Sharing Access Criteria
Publication in Open Acess
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Diseases
-
King's College Hospital NHS TrustSamsung MedisonRecruitingHepatitis | Liver Fat | NAFLD | Fibrosis, Liver | Liver Disease Chronic | Liver Steatoses | NASH With FibrosisUnited Kingdom
-
Beijing Chao Yang HospitalUnknownLiver Transplantation | End Stage Liver DIseaseChina
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Beijing Friendship HospitalUnknownNonalcoholic Fatty Liver Disease | Liver Steatosis | Liver FibrosisChina
-
Medical College of WisconsinRecruiting
-
Shiraz University of Medical SciencesCompletedFatty Liver | Fatty Liver, NonalcoholicIran, Islamic Republic of
-
HaEmek Medical Center, IsraelTerminatedPatients With Fatty Liver DiseaseIsrael
-
Johannes Gutenberg University MainzUniversity of JenaCompletedNon-alcoholic Fatty Liver Disease | Fatty Liver, NonalcoholicGermany
-
The Cleveland ClinicCompleted
-
Hadassah Medical OrganizationUnknown
Clinical Trials on Sylimarin and Sylibin
-
Sohag UniversityRecruiting
-
Shenzhen Geno-Immune Medical InstituteUnknown
-
University Hospitals Cleveland Medical CenterUnknownAsthma | Allergic Rhinitis | Allergic ConjunctivitisUnited States
-
Rutgers, The State University of New JerseyNational Institute on Drug Abuse (NIDA); University of UtahRecruitingTobacco Use | Opioid Use | Polysubstance AbuseUnited States
-
University of North Carolina, Chapel HillCompletedIntestinal Volvulus | Colon, SigmoidMalawi
-
University of JohannesburgCompletedOsteoarthritisSouth Africa
-
Wayne State UniversityUniversity of Michigan; St. John Providence HospitalCompleted
-
University of GlasgowCompleted
-
Turku University HospitalUniversity of TurkuRecruitingProstate Cancer | Prostate HyperplasiaFinland
-
University of TorontoCompletedObesity | Diabetes Mellitus, Type 2Canada