HealthyNCT07379177
Evaluation of the Pharmacokinetics of Curcumin Capsules in Healthy Human
A study testing Curcumin and Nanocurcumin in people with Healthy, run by Kingdomway (Inner Mongolia) Nutritional Food Co., Ltd. at 1 site in China.
Trial summary
Main objective: Through blood drug concentration testing, evaluate the post-meal pharmacokinetic characteristics of the curcumin product compared to similar products, and assess the differences in body exposure between the self-developed product and the control product in healthy trial participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Curcumin and Nanocurcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2026to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both men and women are eligible; women must be non-pregnant and non-lactating.
- Healthy trial participants aged 18 to 65 years (inclusive of the threshold value).
- Body Mass Index (BMI) = weight (kg) / height² (m²), with BMI within the range of 18.5 to 30.0 kg/m² (including the threshold value); male trial participants must have a weight of ≥ 50.0 kg, and female trial participants must have a weight of ≥ 45.0 kg.
- Voluntary participants who have signed the informed consent form; the process of obtaining the informed consent form complies with GCP.
- Female trial participants agree to use effective non-pharmacological methods for appropriate contraception 2 weeks before the trial diet (for male trial participants, starting from the first trial diet), and within 3 months after the last trial diet, and have no plans for egg donation (male sperm donation).
Who cannot join
- Select those who have abnormal and clinically significant findings in physical examination, vital sign examination, blood routine, blood biochemistry, coagulation function, blood pregnancy test (only for females), urine routine, 12-lead electrocardiogram, HBsAg, HCV antibody, HIV antibody, syphilis screening, etc.;
- Those with a history of serious diseases in cardiovascular, endocrine, digestive, respiratory, urinary, immune system and nervous system, or those who developed the above-mentioned diseases during the screening period, and whose research doctors consider them unsuitable to participate in the clinical trial;
- Those who are allergic to two or more drugs or foods (including lactose-intolerant individuals); or those who are prone to asthma, rash, urticaria, etc.; or those who have a known history of allergy to curcumin or any excipients;
- Those with a history of mental illness, drug abuse history, or drug dependence history;
- Those who have used any prescription drugs, over-the-counter drugs, herbal medicine or health supplements within 14 days before the first trial meal (excluding topical preparations or local drug preparations);
- Those who have smoked an average of more than 5 cigarettes per day within the previous 3 months;
Show all 19Show fewer
- Those who have difficulty in blood collection or cannot tolerate venipuncture blood collection;
- Those who have a history of heavy drinking (more than 14 units of alcohol per day, 1 unit = 360 mL beer or 45 mL 40% spirituous alcohol or 150 mL wine) or who do not agree to stop consuming alcoholic products during the trial period (from the screening day to the last cycle discharge);
- Those who have used drugs within the previous 3 months, or those with a positive drug abuse screening result;
- Those who have consumed excessive tea, coffee or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day within the previous 3 months;
- Those who have donated blood or suffered massive blood loss (more than 200 mL) within the previous 3 months;
- Those who participated in any drug clinical trial and used any clinical trial drugs within the previous 3 months;
- Those with special dietary requirements and cannot follow the unified diet;
- Those who have taken special diets or other diets that affect drug absorption, distribution, metabolism, and excretion factors within 7 days before the first trial meal;
- Those who have had acute diseases during the screening stage or before the allocation of the trial number;
- Those whose alcohol breath test result is not 0 mg/100 mL within the first cycle;
- Those who voluntarily withdraw from the trial;
- Those judged by the researchers to be unsuitable to participate;
- The number of participants has reached the limit and the screening number of this trial participant is at the rear.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No. 55, Zhenhai Road
Xiamen, Fujian, 361022
Xi Luo, 86-18359710335, luoxi2999@163.com
Jianfeng Liu, 86-13860426695, liujf5781@sina.com
About this study
Main objective:
Through blood drug concentration testing, evaluate the post-meal pharmacokinetic characteristics of the curcumin product compared to similar products, and assess the differences in body exposure between the self-developed product and the control product in healthy trial participants.
Secondary objective:
Observe the safety of the self-developed product and the control product in healthy trial participants.
Study population:
Healthy male individuals or non-pregnant non-lactating females
- Conditions
- Healthy
- Being tested
- Curcumin, Nanocurcumin
- Keywords
- curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
In the first cycle, take 4 capsules of the self-developed product (T, Nano Curcumin Capsules) (125 mg per capsule), in the second cycle take 2 capsules of the control product (R, Curcumin Capsules) (250 mg per capsule), take with 240 mL of water, and the cleansing period is 7 days.
NanocurcuminDietary supplement
In the first cycle, take 2 capsules (250mg each) of the control product (R, Curcumin Capsules). In the second cycle, take 4 capsules (125mg each) of the self-developed product (T, Nano Curcumin Capsules). Take with 240 mL of water and the cleansing period is 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Nano Curcumin Capsules | Experimental | Test Group Receives: Dietary Supplement: Nanocurcumin |
| Curcumin Capsules | Active comparator | Reference Group Receives: Dietary Supplement: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) 0-t
plasma concentration-time curve from zero to the time of the last measurable time point t
Measured: 2 weeks
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 2 weeks
Area under the plasma concentration versus time curve (AUC)0-∞
area under the plasma concentration-time curve from zero to infinity
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion7 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kingdomway (Inner Mongolia) Nutritional Food Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379177
- Sponsor's protocol ID
- [2026]Ethical Audit No. (001)
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics of Curcumin Capsules in Healthy Human
- ClinicalTrials.gov ID
- NCT07379177
- Acronym / sponsor ID
- [2026]Ethical Audit No. (001)
- Conditions
- Healthy
- Keywords
- curcumin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kingdomway (Inner Mongolia) Nutritional Food Co., Ltd.University, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 7 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Jan 2026 (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.
Main objective:
Through blood drug concentration testing, evaluate the post-meal pharmacokinetic characteristics of the curcumin product compared to similar products, and assess the differences in body exposure between the self-developed product and the control product in healthy trial participants.
Secondary objective:
Observe the safety of the self-developed product and the control product in healthy trial participants.
Study population:
Healthy male individuals or non-pregnant non-lactating females
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano Curcumin Capsules | Experimental | Dietary Supplement: NanocurcuminTest Group |
| Curcumin Capsules | Active comparator | Dietary Supplement: CurcuminReference Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both men and women are eligible; women must be non-pregnant and non-lactating.
- Healthy trial participants aged 18 to 65 years (inclusive of the threshold value).
- Body Mass Index (BMI) = weight (kg) / height² (m²), with BMI within the range of 18.5 to 30.0 kg/m² (including the threshold value); male trial participants must have a weight of ≥ 50.0 kg, and female trial participants must have a weight of ≥ 45.0 kg.
- Voluntary participants who have signed the informed consent form; the process of obtaining the informed consent form complies with GCP.
- Female trial participants agree to use effective non-pharmacological methods for appropriate contraception 2 weeks before the trial diet (for male trial participants, starting from the first trial diet), and within 3 months after the last trial diet, and have no plans for egg donation (male sperm donation).
Key exclusion criteria (19 listed)
- Select those who have abnormal and clinically significant findings in physical examination, vital sign examination, blood routine, blood biochemistry, coagulation function, blood pregnancy test (only for females), urine routine, 12-lead electrocardiogram, HBsAg, HCV antibody, HIV antibody, syphilis screening, etc.;
- Those with a history of serious diseases in cardiovascular, endocrine, digestive, respiratory, urinary, immune system and nervous system, or those who developed the above-mentioned diseases during the screening period, and whose research doctors consider them unsuitable to participate in the clinical trial;
- Those who are allergic to two or more drugs or foods (including lactose-intolerant individuals); or those who are prone to asthma, rash, urticaria, etc.; or those who have a known history of allergy to curcumin or any excipients;
- Those with a history of mental illness, drug abuse history, or drug dependence history;
- Those who have used any prescription drugs, over-the-counter drugs, herbal medicine or health supplements within 14 days before the first trial meal (excluding topical preparations or local drug preparations);
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 |
|---|---|---|
| CurcuminIn the first cycle, take 4 capsules of the self-developed product (T, Nano Curcumin Capsules) (125 mg per capsule), in the second cycle take 2 capsules of the control product (R, Curcumin Capsules) (250 mg per capsule), take with 240 mL of water, and the cleansing period is 7 days. | Dietary supplement | Curcumin Capsules |
| NanocurcuminIn the first cycle, take 2 capsules (250mg each) of the control product (R, Curcumin Capsules). In the second cycle, take 4 capsules (125mg each) of the self-developed product (T, Nano Curcumin Capsules). Take with 240 mL of water and the cleansing period is 7 days. | Dietary supplement | Nano Curcumin Capsules |
Primary outcome
Area under the plasma concentration versus time curve (AUC) 0-t
Time frame: 2 weeks
plasma concentration-time curve from zero to the time of the last measurable time point t
Peak Plasma Concentration (Cmax)
Time frame: 2 weeks
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 2 weeks
area under the plasma concentration-time curve from zero to infinity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin and Nanocurcumin in people with Healthy, run by Kingdomway (Inner Mongolia) Nutritional Food Co., Ltd. at 1 site in China.
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 5 inclusion and 19 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: opening soon, as of the sponsor's last update on 30 Jan 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiyue Liu (86-15952401034, qiyue.liu@cxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) 0-t (time frame: 2 weeks). The study lists 3 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 30 Jan 2026.