Study to Investigate the Absolute Bioavailability of Oral Sylibin

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)

Overall Status

Completed

CT.gov ID

NCT02633696

Collaborator

Fundación Mutua Madrileña (Other)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: silybin phosphatidylcholine Drug: Legalón SIL	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Legalón Sil i.v 350 mg 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
Experimental: Silybin-phosphatidylcholine oral 360 mg 8 healthy volunteers received 9 capsules of 40 mg of sylibin each one (360 mg in total) orally.	Drug: silybin phosphatidylcholine

Arm

Intervention/Treatment

Active Comparator: Legalón Sil i.v 350 mg

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

Experimental: Silybin-phosphatidylcholine oral 360 mg

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

Drug: silybin phosphatidylcholine

Outcome Measures

Primary Outcome Measures

Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups. [1 Month]
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.
Sylibin pharmacokinetic parameters: Area under the curve (AUC) obtained in the different treatment groups. [1 Month]
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.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.