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Trial record 5 of 728 for:    Area Under Curve AND Bioavailability

Study to Investigate the Absolute Bioavailability of Oral Sylibin

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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

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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: silybin phosphatidylcholine Drug: Legalón SIL Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Silymarin

Arm Intervention/treatment
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).
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.
Drug: silybin phosphatidylcholine



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633696


Locations
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Spain
Hospital Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Fundación Mutua Madrileña
Investigators
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Principal Investigator: Mónica Aguilar, MD Hospital Universitario Ramon y Cajal

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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02633696     History of Changes
Other Study ID Numbers: PK-SIL-FARMA03
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: December 2015
Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
Clinical trial
Phase I
Healthy volunteers
Clinical Pharmacology
Bioavailability
Silybin
Liver Trasplantation
Additional relevant MeSH terms:
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Silybin
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents