NCT02633696

Study to Investigate the Absolute Bioavailability of Oral Sylibin

Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This clinical trial phase I in healthy volunteers is intended to describe the oral bioavailability of the silybin-phosphatidylcholine complex by calculating the area under the curve (AUC0-? and AUC0-12) after administration of the same dose of oral silybin (AUCo) and intravenous silybin (AUC iv).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	silybin phosphatidylcholine
DRUG	Legalón SIL

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-11-01
• Completion: 2014-11-01
• First posted: 2015-12-17
• Last updated: 2016-07-11

Locations

1 site across 1 country: Spain