Theracurmin vs Curcumin Bioavailability Study

Handok

Status: Completed

Conditions: Bioavailability

Treatments: Dietary Supplement: curmin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04028739

TC_BA

Details and patient eligibility

About

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

Full description

• 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

Enrollment: 24 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Healthy adult 19 to 60 years
2. BMI 18.0~30.0kg/m2 at screening
3. 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

1. 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.
2. 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.
3. Persons who have an irritable reaction to foods containing turmeric or other drugs and food.
4. Those who took medicines within 7 days before the first intake of food for clinical research.
5. 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.
6. Those who have participated in other clinical studies within 90 days prior to the first intake of food for clinical research.
7. 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Theracurmin CR-033P

Experimental group

Description:

1 Capsule with 150mL water, Single, curcumin 90mg/day

Treatment:

Dietary Supplement: curmin

Theracurmin CR-031P

Experimental group

Description:

3 Capsule with 150mL water, Single, curcumin 90mg/day

Treatment:

Dietary Supplement: curmin

Curcumin

Experimental group

Description:

1 Capsule with 150mL water, Single, curcumin 90mg/day

Treatment:

Dietary Supplement: curmin