Healthy Volunteers
Conditions
Keywords
Clinical trial, Phase I, Healthy volunteers, Clinical Pharmacology, Bioavailability, Silybin, Liver Trasplantation
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).
Interventions
DRUGsilybin phosphatidylcholine
DRUGLegalón SIL
Sponsors
Fundación Mutua Madrileña
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed