BioavailabilityNCT04028739
Theracurmin vs Curcumin Bioavailability Study
A study testing curmin in people with Bioavailability, run by Handok Inc. at 1 site in South Korea.
Trial summary
A randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- curmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2019to 29 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Bioavailability
- Being tested
- curmin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curminDietary supplement
Also called Theracurmin CR-033P, Theracurmin CR-031P, Curcumin
curcumin 90mg/day cross-over
| Study group | Role | What they receive |
|---|---|---|
| Theracurmin CR-033P | Experimental | 1 Capsule with 150mL water, Single, curcumin 90mg/day Receives: Dietary Supplement: curmin |
| Theracurmin CR-031P | Experimental | 3 Capsule with 150mL water, Single, curcumin 90mg/day Receives: Dietary Supplement: curmin |
| Curcumin | Experimental | 1 Capsule with 150mL water, Single, curcumin 90mg/day Receives: Dietary Supplement: curmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration at steady state
Measured: 12hours
AUC
Area under the concentration-time curve at steady state
Measured: 12hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start31 Jul 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyewon Chung, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028739
- Sponsor's protocol ID
- TC_BA
- Status last verified
- Dec 2019
- First submitted
- 17 Jul 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Cross-over, Single Administration Study to Compare Bioavailability of Curcumin in Health Adults
- ClinicalTrials.gov ID
- NCT04028739
- Acronym / sponsor ID
- TC_BA
- Conditions
- Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Theracurmin CR-033P | Experimental | Dietary Supplement: curmin1 Capsule with 150mL water, Single, curcumin 90mg/day |
| Theracurmin CR-031P | Experimental | Dietary Supplement: curmin3 Capsule with 150mL water, Single, curcumin 90mg/day |
| Curcumin | Experimental | Dietary Supplement: curmin1 Capsule with 150mL water, Single, curcumin 90mg/day |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curminAlso: Theracurmin CR-033P, Theracurmin CR-031P, Curcumincurcumin 90mg/day cross-over | Dietary supplement | Curcumin, Theracurmin CR-031P, Theracurmin CR-033P |
Primary outcome
Cmax
Time frame: 12hours
Maximum concentration at steady state
AUC
Time frame: 12hours
Area under the concentration-time curve at steady state
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyewon Chung principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curmin in people with Bioavailability, run by Handok Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 12hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.