NCT07379177尚未招募不适用
Evaluation of the Pharmacokinetics of Curcumin Capsules in Healthy Human
Kingdomway (Inner Mongolia) Nutritional Food Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年1月28日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) 0-t
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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;
- •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.
研究组 & 干预措施
Nano Curcumin Capsules
Experimental
Test Group
干预措施: Nanocurcumin (Dietary Supplement)
Curcumin Capsules
Active Comparator
Reference Group
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) 0-t
时间窗: 2 weeks
plasma concentration-time curve from zero to the time of the last measurable time point t
Peak Plasma Concentration (Cmax)
时间窗: 2 weeks
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 2 weeks
area under the plasma concentration-time curve from zero to infinity
次要结局
未报告次要终点
研究者
研究点 (1)
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