Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Investigate the Absolute Bioavailability of Oral Sylibin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633696
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Tracking Information
First Submitted Date  ICMJE December 10, 2015
First Posted Date  ICMJE December 17, 2015
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02633696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • Sylibin pharmacokinetic parameters:Tmax, obtained in the different treatment groups. [ Time Frame: 1 Month ]
  • Sylibin pharmacokinetic parameters:t1/2, obtained in the different treatment groups. [ Time Frame: 1 Month ]
  • To estimate the inter and intraindividual coefficient of variation (CV) [ Time Frame: 1 Month ]
  • To evaluate the safety (adverse events, laboratory abnormalities) and tolerability [ Time Frame: 2 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Absolute Bioavailability of Oral Sylibin
Official Title  ICMJE Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: silybin phosphatidylcholine
  • Drug: Legalón SIL
Study Arms  ICMJE
  • 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).
    Intervention: 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.
    Intervention: Drug: silybin phosphatidylcholine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2015)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02633696
Other Study ID Numbers  ICMJE PK-SIL-FARMA03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Sponsor  ICMJE Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators  ICMJE Fundación Mutua Madrileña
Investigators  ICMJE
Principal Investigator: Mónica Aguilar, MD Hospital Universitario Ramon y Cajal
PRS Account Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP