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Completed

NCT Number: NCT02633696

Study to Investigate the Absolute Bioavailability of Oral Sylibin

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).

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

silybin phosphatidylcholine

Drug

Legalón SIL

Drug

Primary outcomes

  1. Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups.

    Time frame: 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.

  2. Sylibin pharmacokinetic parameters: Area under the curve (AUC) obtained in the different treatment groups.

    Time frame: 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 outcomes

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

    Time frame: 1 Month

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

    Time frame: 1 Month

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

    Time frame: 1 Month

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

    Time frame: 2 Months

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Fundación Mutua Madrileña

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 17, 2015
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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