Bioavailability and PharmacokineticsNCT06882681
Silymarin Bioavailability Study
A study testing LipoMicel Milk Thistle and Unformulated Milk Thistle Extract in people with Bioavailability and Pharmacokinetics, run by Isura at 1 site in Canada.
Trial summary
This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability and Pharmacokinetics
- What is being tested?
- LipoMicel Milk Thistle and Unformulated Milk Thistle Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 31 Jan 2025
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 21- 65 years
- Healthy, good physical condition
- Voluntary, written, informed consent to participate in the study.
Who cannot join
- Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases
- Contraindication or allergies to milk thistle
- Pregnancy or breastfeeding
- Concurrent use of supplements and/or medications
- Participation in another investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Micellar Formulation of Silymarin with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial
This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.
- Conditions
- Bioavailability and Pharmacokinetics
- Being tested
- LipoMicel Milk Thistle, Unformulated Milk Thistle Extract
- Keywords
- milk thistle, silymarin, LipoMicel, pharmacokinetics, bioavailability, absorption, micelles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoMicel Milk ThistleDietary supplement
A maximum single dose of approx. 140 mg silymarin (in soft gel capsule)
Unformulated Milk Thistle ExtractDietary supplement
A maximum single dose of approx. 130 mg silymarin (in hard gel capsules)
| Study group | Role | What they receive |
|---|---|---|
| LipoMicel Milk Thistle | Experimental | Participants receive their treatment of a novel micellar Milk Thistle formulation (i.e, LipoMicel soft-gel capsules) at a total dose of approx. 140 mg of silymarins per capsule. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used. Receives: Dietary Supplement: LipoMicel Milk Thistle |
| Unformulated/Standard Milk Thistle Extract | Experimental | Participants receive their treatment of standard/unformulated Milk Thistle (i.e, hard-gel capsules) at a total dose of approx. 130 mg of silymarins per capsule. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used. Receives: Dietary Supplement: Unformulated Milk Thistle Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC: the area under the concentration-time curve
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing silymarin.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Cmax: maximum plasma concentration
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing silymarin.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Tmax: the time point of maximum plasma concentration
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing silymarin.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
MRT: Mean residence time
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the mean residence time (MRT) with that of other capsules containing silymarin.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
T1/2: elimination half-life
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the elimination half-life (T1/2) with that of other capsules containing silymarin.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 May 2024
- Primary completion20 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability and PharmacokineticsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Solnier, PhD, Principal investigator, Isura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882681
- Sponsor's protocol ID
- 2022-11-002S
- Status last verified
- Jan 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Micellar Formulation of Silymarin with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial
- ClinicalTrials.gov ID
- NCT06882681
- Acronym / sponsor ID
- 2022-11-002S
- Conditions
- Bioavailability and Pharmacokinetics
- Keywords
- milk thistle, silymarin, LipoMicel, pharmacokinetics, bioavailability, absorption, micelles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IsuraUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Mar 2025 (actual)
- 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 study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LipoMicel Milk Thistle | Experimental | Dietary Supplement: LipoMicel Milk ThistleParticipants receive their treatment of a novel micellar Milk Thistle formulation (i.e, LipoMicel soft-gel capsules) at a total dose of approx. 140 mg of silymarins per capsule. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used. |
| Unformulated/Standard Milk Thistle Extract | Experimental | Dietary Supplement: Unformulated Milk Thistle ExtractParticipants receive their treatment of standard/unformulated Milk Thistle (i.e, hard-gel capsules) at a total dose of approx. 130 mg of silymarins per capsule. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 21- 65 years
- Healthy, good physical condition
- Voluntary, written, informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases
- Contraindication or allergies to milk thistle
- Pregnancy or breastfeeding
- Concurrent use of supplements and/or medications
- Participation in another investigational study
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 |
|---|---|---|
| LipoMicel Milk ThistleA maximum single dose of approx. 140 mg silymarin (in soft gel capsule) | Dietary supplement | LipoMicel Milk Thistle |
| Unformulated Milk Thistle ExtractA maximum single dose of approx. 130 mg silymarin (in hard gel capsules) | Dietary supplement | Unformulated/Standard Milk Thistle Extract |
Primary outcome
AUC: the area under the concentration-time curve
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing silymarin.
Cmax: maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing silymarin.
Tmax: the time point of maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing silymarin.
MRT: Mean residence time
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the mean residence time (MRT) with that of other capsules containing silymarin.
T1/2: elimination half-life
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the elimination half-life (T1/2) with that of other capsules containing silymarin.
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 18 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Julia Solnier, PhD principal investigator
Isura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LipoMicel Milk Thistle and Unformulated Milk Thistle Extract in people with Bioavailability and Pharmacokinetics, run by Isura at 1 site in Canada.
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 3 inclusion and 5 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 18 Mar 2025. 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 Canada. 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.
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?
AUC: the area under the concentration-time curve (time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)). The study lists 5 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 18 Mar 2025.