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| Name | Class |
|---|---|
| Boston Biopharm, Inc. | OTHER |
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This study is investigating the pharmacokinetic profile (i.e. the way the product is processed by the body) of a proprietary curcumin formulation compared to an unformulated curcumin product. Subjects will take a single dose of either the proprietary formulation or comparator product and the blood levels of curcumin and curcumin metabolites will be measured over a period of 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Sequence 1 | Experimental | Proprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second |
|
| Dosing Sequence 2 | Experimental | Unformulated Comparator Curcumin Product administered first, Proprietary Curcumin Formulation administered second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proprietary Curcumin Formulation | Dietary Supplement |
| ||
| Unformulated Comparator Curcumin Product |
| Measure | Description | Time Frame |
|---|---|---|
| Curcumin AUC | Area Under the Curve | Time 0 to 48 hours |
| Curcumin Cmax | Maximum Concentration | Time 0 to 48 hours |
| Curcumin Tmax | Time until maximum concentration | Time 0 to 48 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Time 0 to 48 hours | |
| Changes in blood CBC levels | Time 0 to 48 hours | |
| Changes in blood electrolyte levels |
Inclusion Criteria:
Male and females 18-45 years of age
If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
BMI 18-29.9 kg/m2 (±1 kg/m2)
Healthy as determined by laboratory results and medical history
Agrees to maintain current level of physical activity throughout the study
Agree to avoid using black or white pepper, turmeric, curcumin or curry in the preparation of food for 7 days prior to randomization and throughout the study period.
Agree to avoid Indian and Thai cuisines for the period of the study
Agree to avoid food with yellow dye #E100
Agrees to avoid alcohol, caffeine 12 hours and grapefruit and grapefruit juice 48 hours prior to baseline and each subsequent clinic visit
Agrees to consume only low polyphenols in the diet (nutritionists will counsel on high polyphenol fruits, vegetables to avoid, wine, beer, supplements, herbal extracts, and whole-grain based foods) 3 days prior to baseline and on test days (meal options and lists of foods to avoid will be provided to subjects by nutritionists)
Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Dietary Supplement |
|
| Time 0 to 48 hours |
| Changes in blood creatinine levels | Time 0 to 48 hours |
| Changes in blood AST levels | Time 0 to 48 hours |
| Changes in blood ALT levels | Time 0 to 48 hours |
| Changes in blood GGT levels | Time 0 to 48 hours |
| Changes in blood bilirubin levels | Time 0 to 48 hours |