Theracurmin vs Curcumin Bioavailability Study
A Randomized, Open-label, Cross-over, Single Administration Study to Compare Bioavailability of Curcumin in Health Adults
1 other identifier
interventional
24
1 country
1
Brief Summary
A randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedStudy Start
First participant enrolled
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2019
CompletedDecember 6, 2019
December 1, 2019
4 months
July 17, 2019
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax
Maximum concentration at steady state
12hours
AUC
Area under the concentration-time curve at steady state
12hours
Study Arms (3)
Theracurmin CR-033P
EXPERIMENTAL1 Capsule with 150mL water, Single, curcumin 90mg/day
Theracurmin CR-031P
EXPERIMENTAL3 Capsule with 150mL water, Single, curcumin 90mg/day
Curcumin
EXPERIMENTAL1 Capsule with 150mL water, Single, curcumin 90mg/day
Interventions
curcumin 90mg/day cross-over
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Handok Inc.lead
Study Sites (1)
Korea Kuro Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyewon Chung
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 23, 2019
Study Start
July 31, 2019
Primary Completion
November 29, 2019
Study Completion
November 29, 2019
Last Updated
December 6, 2019
Record last verified: 2019-12