Clinical trial NCT02633696: Study to Investigate the Absolute Bioavailability of Oral Sylibin
Official title: Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Clinical trial
Phase I
Healthy volunteers
Clinical Pharmacology
Bioavailability
Silybin
Liver Trasplantation
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2015-12-17
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups.
timeFrame: 1 Month
measure: Sylibin pharmacokinetic parameters: Area under the curve (AUC) obtained in the different treatment groups.
timeFrame: 1 Month
Secondary outcomes:
measure: Sylibin pharmacokinetic parameters:Tmax, obtained in the different treatment groups.
timeFrame: 1 Month
measure: Sylibin pharmacokinetic parameters:t1/2, obtained in the different treatment groups.
timeFrame: 1 Month
measure: To estimate the inter and intraindividual coefficient of variation (CV)
timeFrame: 1 Month
measure: To evaluate the safety (adverse events, laboratory abnormalities) and tolerability
timeFrame: 2 Months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Mónica Aguilar, MD
role: PRINCIPAL_INVESTIGATOR
References: