Theracurmin vs Curcumin Bioavailability Study

Not Applicable

Completed

• Conditions: Bioavailability
• Interventions: Dietary Supplement: curmin

• Registration Number: NCT04028739
• Lead Sponsor: Handok Inc.

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-23
• Study Start: 2019-07-31
• Primary Completion: 2019-11-29
• Study Completion: 2019-11-29
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Theracurmin CR-031P	curmin	3 Capsule with 150mL water, Single, curcumin 90mg/day
Theracurmin CR-033P	curmin	1 Capsule with 150mL water, Single, curcumin 90mg/day
Curcumin	curmin	1 Capsule with 150mL water, Single, curcumin 90mg/day

Primary Outcome Measures

Name	Time	Method
Cmax	12hours	Maximum concentration at steady state
AUC	12hours	Area under the concentration-time curve at steady state

Trial Locations

Locations (1)

Korea Kuro Hospital; 🇰🇷 Seoul, Korea, Republic of