- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028739
Theracurmin vs Curcumin Bioavailability Study
December 4, 2019 updated by: Handok Inc.
A Randomized, Open-label, Cross-over, Single Administration Study to Compare Bioavailability of Curcumin in Health Adults
A randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults
Study Overview
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Korea Kuro Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Theracurmin CR-033P
1 Capsule with 150mL water, Single, curcumin 90mg/day
|
curcumin 90mg/day cross-over
Other Names:
|
Experimental: Theracurmin CR-031P
3 Capsule with 150mL water, Single, curcumin 90mg/day
|
curcumin 90mg/day cross-over
Other Names:
|
Experimental: Curcumin
1 Capsule with 150mL water, Single, curcumin 90mg/day
|
curcumin 90mg/day cross-over
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 12hours
|
Maximum concentration at steady state
|
12hours
|
AUC
Time Frame: 12hours
|
Area under the concentration-time curve at steady state
|
12hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: HyeWon Chung, Korea University Guro Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2019
Primary Completion (Actual)
November 29, 2019
Study Completion (Actual)
November 29, 2019
Study Registration Dates
First Submitted
July 17, 2019
First Submitted That Met QC Criteria
July 18, 2019
First Posted (Actual)
July 23, 2019
Study Record Updates
Last Update Posted (Actual)
December 6, 2019
Last Update Submitted That Met QC Criteria
December 4, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- TC_BA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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