NCT06882681

Brief Summary

This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

March 12, 2025

Last Update Submit

March 12, 2025

Conditions

Bioavailability and Pharmacokinetics

Keywords

milk thistlesilymarinLipoMicelpharmacokineticsbioavailabilityabsorptionmicelles

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

Study Arms (2)

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.

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.

Dietary Supplement: Unformulated Milk Thistle Extract

Interventions

LipoMicel Milk ThistleDIETARY_SUPPLEMENT

A maximum single dose of approx. 140 mg silymarin (in soft gel capsule)

LipoMicel Milk Thistle
Unformulated Milk Thistle ExtractDIETARY_SUPPLEMENT

A maximum single dose of approx. 130 mg silymarin (in hard gel capsules)

Unformulated/Standard Milk Thistle Extract

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 21- 65 years
  • Healthy, good physical condition
  • Voluntary, written, informed consent to participate in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISURA

Burnaby, British Columbia, V2N 4S9, Canada

Location

Study Officials

  • Julia Solnier, PhD

    Isura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 18, 2025

Study Start

May 1, 2024

Primary Completion

December 20, 2024

Study Completion

January 31, 2025

Last Updated

March 18, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)