Study to Investigate the Absolute Bioavailability of Oral Sylibin

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Legalón SIL

Drug: silybin phosphatidylcholine

Study type

Interventional

Funder types

Other

Identifiers

NCT02633696

PK-SIL-FARMA03

Details and patient eligibility

About

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).

Enrollment

8 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.