Healthy VolunteersPhase 1NCT02633696
Study to Investigate the Absolute Bioavailability of Oral Sylibin
A Phase 1 study testing silybin phosphatidylcholine and Legalón SIL in people with Healthy Volunteers, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- silybin phosphatidylcholine and Legalón SIL
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin
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).
- Conditions
- Healthy Volunteers
- Being tested
- silybin phosphatidylcholine, Legalón SIL
- Keywords
- Clinical trial, Phase I, Healthy volunteers, Clinical Pharmacology, Bioavailability, Silybin, Liver Trasplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silybin phosphatidylcholineDrug
Legalón SILDrug
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Legalón SIL |
| Silybin-phosphatidylcholine oral 360 mg | Experimental | 8 healthy volunteers received 9 capsules of 40 mg of sylibin each one (360 mg in total) orally. Receives: Drug: silybin phosphatidylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Month
Secondary outcomes (4)
Sylibin pharmacokinetic parameters:Tmax, obtained in the different treatment groups.
Measured: 1 Month
Sylibin pharmacokinetic parameters:t1/2, obtained in the different treatment groups.
Measured: 1 Month
To estimate the inter and intraindividual coefficient of variation (CV)
Measured: 1 Month
To evaluate the safety (adverse events, laboratory abnormalities) and tolerability
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Sponsor
- Investigators
- Mónica Aguilar, MD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633696
- Sponsor's protocol ID
- PK-SIL-FARMA03
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability of Oral Sylibin
- ClinicalTrials.gov ID
- NCT02633696
- Acronym / sponsor ID
- PK-SIL-FARMA03
- Conditions
- Healthy Volunteers
- Keywords
- Clinical trial, Phase I, Healthy volunteers, Clinical Pharmacology, Bioavailability, Silybin, Liver Trasplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Legalón Sil i.v 350 mg | Active comparator | Drug: Legalón SIL8 healthy volunteers received 1 vial of 350 mg iv of sylibin lyophilisate for solution for infusion (legalon sil) in two hours (single dose). |
| Silybin-phosphatidylcholine oral 360 mg | Experimental | Drug: silybin phosphatidylcholine8 healthy volunteers received 9 capsules of 40 mg of sylibin each one (360 mg in total) orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silybin phosphatidylcholine | Drug | Silybin-phosphatidylcholine oral 360 mg |
| Legalón SIL | Drug | Legalón Sil i.v 350 mg |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mónica Aguilar, MD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing silybin phosphatidylcholine and Legalón SIL in people with Healthy Volunteers, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sylibin pharmacokinetic parameters: Maximum plasma concentration (Cmax) obtained in the different treatment groups. (time frame: 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.