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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Hospital Ramón y Cajal
Madrid, Madrid, Spain
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.
Time frame: 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.
Time frame: 1 Month
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
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