Study to Investigate the Absolute Bioavailability of Oral Sylibin

NCT02633696 | Completed Phase 1

• 1 other identifier: PK-SIL-FARMA03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Clinical trial; Phase I; Healthy volunteers; Clinical Pharmacology; Bioavailability; Silybin; Liver Trasplantation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Sylibin pharmacokinetic parameters:Tmax, obtained in the different treatment groups.

  1 Month

• Sylibin pharmacokinetic parameters:t1/2, obtained in the different treatment groups.

  1 Month

• To estimate the inter and intraindividual coefficient of variation (CV)

  1 Month

• To evaluate the safety (adverse events, laboratory abnormalities) and tolerability

  2 Months

Study Arms (2)

Legalón Sil i.v 350 mg

ACTIVE COMPARATOR

8 healthy volunteers received 1 vial of 350 mg iv of sylibin lyophilisate for solution for infusion (legalon sil) in two hours (single dose).

Drug: Legalón SIL

Silybin-phosphatidylcholine oral 360 mg

EXPERIMENTAL

8 healthy volunteers received 9 capsules of 40 mg of sylibin each one (360 mg in total) orally.

Drug: silybin phosphatidylcholine

Interventions

silybin phosphatidylcholine DRUG

Silybin-phosphatidylcholine oral 360 mg

Legalón SIL DRUG

Legalón Sil i.v 350 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Fundación Mutua Madrileña: collaborator

Study Sites (1)

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Interventions

IdB 1016

Study Officials

• Mónica Aguilar, MD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: July 11, 2016

Record last verified: 2015-12

Locations

ES (1)