Superior Silybin Bioavailability in Healthy Volunteers | NCT03440164

Studies
Superior Silybin Bioavailability in Healthy Volunteers

NCT03440164

Sponsor

Medica Sur Clinic & Foundation

Status

Completed

Last Update Posted

Feb 22, 2018Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Liver Diseases
Chronic Liver Disease

Interventions

Sylimarin and Sylibin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2016Actual

Primary Completion Date

Dec 8, 2016Actual

Completion Date

Dec 15, 2016Actual

First Submitted Date

Feb 14, 2018

First Submission Date that Met QC Criteria

Feb 14, 2018

First Posted Date

Feb 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2018

Last Update Posted Date

Feb 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Medica Sur Clinic & FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sylimarin and Sylibin	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time of the Bioavailability of the Silibinin vs Sylimarin	Analysis of the Bioavailability	One week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

All healthy volunteers

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30635055	Derived	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.

ID	Term
D008107	Liver Diseases
D008103	Liver Cirrhosis

ID	Term
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms