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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipoMicel Milk Thistle | Dietary Supplement | A maximum single dose of approx. 140 mg silymarin (in soft gel capsule) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Solnier, PhD | Isura | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISURA | Burnaby | British Columbia | V2N 4S9 | Canada |
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| Unformulated Milk Thistle Extract | Dietary Supplement | A maximum single dose of approx. 130 mg silymarin (in hard gel capsules) |
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