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Completed

NCT Number: NCT06882681

Silymarin Bioavailability Study

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

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Key information

Conditions

Bioavailability and Pharmacokinetics

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISURA

Burnaby, British Columbia, V2N 4S9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

LipoMicel Milk Thistle

Dietary Supplement

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

Unformulated Milk Thistle Extract

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Isura

Other

Registry information

Official study title

Novel Micellar Formulation of Silymarin with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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