Theracurmin vs Curcumin Bioavailability Study

Study Overview
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Brief Summary
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A randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults

Detailed Description
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Randomization, Open-label, 3-period, 6-sequence, Crossover, Single Drug-free inverval : more than 7 days Sampling time : 0,0.5,1,1.5,2,3,4,6,8,12h

Official Title
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A Randomized, Open-label, Cross-over, Single Administration Study to Compare Bioavailability of Curcumin in Health Adults

Conditions
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Bioavailability

Intervention / Treatment
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* Dietary Supplement: curmin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult 19 to 60 years BMI 18.0 30.0kg/m2 at screening Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements. Exclusion Criteria A person with clinically significant disease corresponding to cardiovascular, respiratory, liver, kidney, digestive system, blood/tumor system, endocrine system, immune system, neuropsychiatry or who has a history within the last 6 months. A person with a history of gastrointestinal disease or surgery (except for simple cecal surgery or hernia surgery) that may affect the absorption of food for clinical research. Persons who have an irritable reaction to foods containing turmeric or other drugs and food. Those who took medicines within 7 days before the first intake of food for clinical research. Food for Clinical Research If you have consumed foods containing turmeric (eg, radishes, curry) within 7 days before the first intake of food, or you can't consume until the day of intake of food for the last clinical study. Those who have participated in other clinical studies within 90 days prior to the first intake of food for clinical research. Women who are pregnant or lactating during screening, or who plan to become pregnant during clinical research. A person who is deemed unsuitable for participating in this clinical study because of other reasons.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theracurmin CR-033P<br>1 Capsule with 150mL water, Single, curcumin 90mg/day | Dietary Supplement: curmin<br>* curcumin 90mg/day cross-over<br>* Other names: Curcumin;|
| Experimental: Theracurmin CR-031P<br>3 Capsule with 150mL water, Single, curcumin 90mg/day | Dietary Supplement: curmin<br>* curcumin 90mg/day cross-over<br>* Other names: Curcumin;|
| Experimental: Curcumin<br>1 Capsule with 150mL water, Single, curcumin 90mg/day | Dietary Supplement: curmin<br>* curcumin 90mg/day cross-over<br>* Other names: Curcumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration at steady state | 12hours | 
| AUC | Area under the concentration-time curve at steady state | 12hours |