NCT03440164

Superior Silybin Bioavailability in Healthy Volunteers

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Medica Sur Clinic & Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Liver Diseases
• Chronic Liver Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-11
• Primary completion: 2016-12-08
• Completion: 2016-12-15
• First posted: 2018-02-22
• Last updated: 2018-02-22