NCT02633696|CompletedPhase 1
Study to Investigate the Absolute Bioavailability of Oral Sylibin
Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin
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Sponsor study identifier
interventional
8
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2014
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 2013
Actual (reported)November 2014
Actual (reported)December 10, 2015
Actual (reported)December 17, 2015
Actual (reported)Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups.
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.
1 Month
Sylibin pharmacokinetic parameters: Area under the curve (AUC) obtained in the different treatment groups.
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.
1 Month
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
8 healthy volunteers received 1 vial of 350 mg iv of sylibin lyophilisate for solution for infusion (legalon sil) in two hours (single dose).
8 healthy volunteers received 9 capsules of 40 mg of sylibin each one (360 mg in total) orally.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Mónica Aguilar, MD
Hospital Universitario Ramon y Cajal
8 participants (actual enrollment reported by the registry).
First Submitted
December 10, 2015
First Posted
December 17, 2015
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
RANDOMIZED, CROSSOVER, TWO-PERIOD, COMPARATIVE BIOAVAILABILITY STUDY OF TWO IBUPROFEN FORMULATIONS, AFTER A SINGLE ORAL DOSE OF 400 MG IN SOLUTION FORM TO HEALTHY SUBJECTS UNDER FASTING CONDITIONS
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
July 11, 2016
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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