Theracurmin vs Curcumin Bioavailability Study

NCT ID: NCT04028739

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2019-11-29

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

Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Theracurmin CR-033P

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

Group Type EXPERIMENTAL

curmin

Intervention Type DIETARY_SUPPLEMENT

curcumin 90mg/day cross-over

Theracurmin CR-031P

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

Group Type EXPERIMENTAL

curmin

Intervention Type DIETARY_SUPPLEMENT

curcumin 90mg/day cross-over

Curcumin

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

Group Type EXPERIMENTAL

curmin

Intervention Type DIETARY_SUPPLEMENT

curcumin 90mg/day cross-over

Interventions

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curmin

curcumin 90mg/day cross-over

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Theracurmin CR-033P Theracurmin CR-031P Curcumin

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyewon Chung

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea Kuro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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TC_BA

Identifier Type: -

Identifier Source: org_study_id