Theracurmin vs Curcumin Bioavailability Study

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028739
• Other study ID #: TC_BA
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: December 2019
• Source: Handok Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• curmin
curcumin 90mg/day cross-over

Locations

Country	Name	City	State
Korea, Republic of	Korea Kuro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum concentration at steady state	12hours
Primary	AUC	Area under the concentration-time curve at steady state	12hours