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| Name | Class |
|---|---|
| Fundación Mutua Madrileña | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Legalón Sil i.v 350 mg | Active Comparator | 8 healthy volunteers received 1 vial of 350 mg iv of sylibin lyophilisate for solution for infusion (legalon sil) in two hours (single dose). |
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| Silybin-phosphatidylcholine oral 360 mg | Experimental | 8 healthy volunteers received 9 capsules of 40 mg of sylibin each one (360 mg in total) orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silybin phosphatidylcholine | Drug |
| ||
| Legalón SIL |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mónica Aguilar, MD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| C067772 | IdB 1016 |
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| Drug |
|
| To estimate the inter and intraindividual coefficient of variation (CV) |
| 1 Month |
| To evaluate the safety (adverse events, laboratory abnormalities) and tolerability | 2 Months |