Evaluation of the Pharmacokinetics of Curcumin Capsules in Healthy Human

Kingdomway (Inner Mongolia) Nutritional Food Co., Ltd.

Status: Not yet enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Nanocurcumin; Dietary Supplement: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT07379177

[2026]Ethical Audit No. (001)

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Both men and women are eligible; women must be non-pregnant and non-lactating.
2. Healthy trial participants aged 18 to 65 years (inclusive of the threshold value).
3. 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.
4. Voluntary participants who have signed the informed consent form; the process of obtaining the informed consent form complies with GCP.
5. 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).

Exclusion criteria

1. 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.;
2. 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;
3. 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;
4. Those with a history of mental illness, drug abuse history, or drug dependence history;
5. 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);
6. Those who have smoked an average of more than 5 cigarettes per day within the previous 3 months;
7. Those who have difficulty in blood collection or cannot tolerate venipuncture blood collection;
8. 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);
9. Those who have used drugs within the previous 3 months, or those with a positive drug abuse screening result;
10. 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;
11. Those who have donated blood or suffered massive blood loss (more than 200 mL) within the previous 3 months;
12. Those who participated in any drug clinical trial and used any clinical trial drugs within the previous 3 months;
13. Those with special dietary requirements and cannot follow the unified diet;
14. 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;
15. Those who have had acute diseases during the screening stage or before the allocation of the trial number;
16. Those whose alcohol breath test result is not 0 mg/100 mL within the first cycle;
17. Those who voluntarily withdraw from the trial;
18. Those judged by the researchers to be unsuitable to participate;
19. The number of participants has reached the limit and the screening number of this trial participant is at the rear.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Nano Curcumin Capsules

Experimental group

Description:

Test Group

Treatment:

Dietary Supplement: Nanocurcumin

Curcumin Capsules

Active Comparator group

Description:

Reference Group

Treatment:

Dietary Supplement: Curcumin