Superior Silybin Bioavailability in Healthy Volunteers

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440164
• Other study ID #: CONBIOETICA14CEI02820131108
• Status: Completed
• Phase: N/A
• First received: February 14, 2018
• Last updated: February 14, 2018
• Start date: November 11, 2016
• Est. completion date: December 15, 2016

Study information

• Verified date: October 2016
• Source: Medica Sur Clinic & Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 15, 2016
• Est. primary completion date: December 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medica Sur Clinic & Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of the Bioavailability of the Silibinin vs Sylimarin	Analysis of the Bioavailability	One week