Study to Investigate the Absolute Bioavailability of Oral Sylibin

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633696
• Other study ID #: PK-SIL-FARMA03
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2015
• Last updated: July 8, 2016
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy individuals men who give their written consent to participate in the study, after having received information about the design, the project objectives, the risks and that at any moment they can refuse their cooperation.

• Understand the purpose of the study and be available for performing hospital visits and and admissions.

• Age between 18 and 45 years.

• Healthy subjects, without any organic or psychological pathology

• Clinical history and physical examination within normal limits.

• Lack of clinically relevant abnormalities in blood test (hematology, biochemistry, virology) and urine test

• Vital signs and electrocardiographic recording in the normal range.

• Males with childbearing potential partners must agree to use a highly effective method of contraception (such as surgical sterilization, double barrier method) from the moment of signing the informed consent until 6 months after the end of their participation in the study.

Exclusion Criteria:

• Subjects suffering from organic or psychological pathology. Prior to the inclusion of any volunteer it should be considered all security parameters mentioned in the protocol (biochemical markers of kidney damage and / or liver out of the normal range set by the laboratory).

• Subjects who have received prescription drug treatment in the last 15 days or any medication within 48 hours before receiving study medication.

• Subjects with a BMI that is not between 18 and 30.

• Known hypersensitivity to any drug

• Suspected of drug abuse

• Consumers of alcohol daily and / or acute alcohol poisoning in the last week.

• Subjects smoking.

• Have donated blood in the last three months.

• Participation in any other investigational drug study in the previous 3 months

• Not to be able to follow instructions or collaborate during the course of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• silybin phosphatidylcholine

• Legalón SIL

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups.	Patient will be hospitalized in the clinical trial unit in order to obtain plasma concentrations previous to the administration of the corresponding dose and at the following times post-administration: : 20min, 40min, 1h, 1h20min, 1h40min 2h, 2h30min, 3h, 4h, 6h, 8h and 12h. Two more plasma concentrations will be obtained at 5 min and 10 mins post- administration of the iv dose. These measures will be calculated in order to describe the bioavailability of oral sylibinobtained in the different treatment groups.	1 Month	No
Primary	Sylibin pharmacokinetic parameters: Area under the curve (AUC) obtained in the different treatment groups.	Patient will be hospitalized in the clinical trial unit in order to obtain plasma concentrations previous to the administration of the corresponding dose and at the following times post-administration: : 20min, 40min, 1h, 1h20min, 1h40min 2h, 2h30min, 3h, 4h, 6h, 8h and 12h. Two more plasma concentrations will be obtained at 5 min and 10 mins post- administration of the iv dose. These measures will be calculated in order to describe the bioavailability of oral sylibinobtained in the different treatment groups.	1 Month	No
Secondary	Sylibin pharmacokinetic parameters:Tmax, obtained in the different treatment groups.		1 Month	No
Secondary	Sylibin pharmacokinetic parameters:t1/2, obtained in the different treatment groups.		1 Month	No
Secondary	To estimate the inter and intraindividual coefficient of variation (CV)		1 Month	No
Secondary	To evaluate the safety (adverse events, laboratory abnormalities) and tolerability		2 Months	Yes