Bioavailability of Curcumin Capsules in Healthy Adult Subjects: an Open, Randomized, Single-dose, Two-period, Two-sequence Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC（AUC0-t，AUC0-∞）
研究概览
简要总结
A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy adult male and female subjects under fasting conditions.
详细描述
Upgraded curcumin capsules(CuminUP60®) is made from curcumin with a natural extraction content of 95% and excipients through physical process microprocessing, with a curcumin content of more than 60%. CuminUP60® capsules are 400 mg/ capsules and ordinary curcumin capsules are 400 mg/ capsules. The main purpose of this study is to evaluate the bioavailability by comparing the pharmacokinetics of CuminUP60® capsule with that of curcumin capsule before the prescription improvement.
12 cases are planned to be enrolled.According to the random table, each subject will be randomly assigned to one of two groups (group 1: A/B, group 2: B/A). The cleaning period between the two doses is 7 days. Subjects were given the test preparation (A) or the control preparation (B) on the first day of the first cycle of the trial, and were temporarily allowed to leave the phase I clinical research center after 72 hours of blood sample collection and vital signs examination after the completion of the medication. After a 7-day wash period, on the 8th day of the second cycle, the subject will be cross-administered with the control formulation (B) or the test formulation (A), all procedures are the same as in the first cycle.
On the 11th day (the second cycle), subjects will undergo physical examination, ECG examination, assessment of vital signs (blood pressure, pulse, body temperature), laboratory examinations (blood biochemistry, blood routine, urine routine, detailed examination items are shown in the appendix 1) Female subjects must undergo a blood pregnancy test and then be allowed to leave the research center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 接受健康志愿者
- 是
入选标准
- •Volunteer to participate in this clinical trial, understand and voluntarily signed a written informed consent;
- •Able to complete the research in accordance with the requirements of the test plan;
- •Subjects (including male subjects) have taken effective contraceptive measures within 14 days before screening and are willing to have no pregnancy plan within 3 months after the end of the study and voluntarily take effective contraceptive measures;
- •Male and female subjects aged 18 to 55 years old (including 18 and 55 years old);
- •Male subjects weigh no less than 50 kg. Female subjects weighed no less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), and the body mass index is within the range of 18.0-28.0 (including the cut-off value).
排除标准
- •Abnormal conditions judged by clinicians to be clinically significant, which the research doctor considers not suitable for participants;
- •A positive test results for hepatitis B virus（HBV）, hepatitis C virus（HCV）, HIV or syphilis;
- •Those who have a history of specific allergies or allergies, or those who are known to be allergic to curcumin components or the like;
- •A history of alcoholism ;
- •A history of dysphagia or any gastrointestinal disease that affects drug absorption;
- •Female subjects are breastfeeding during the screening period or clinical trials or have a positive pregnancy test result;
- •Those who have a positive drug screening test or have a history of drug abuse in the past five years or have used drugs in the 3 months before taking the drug;
- •Those who smoked more than 5 cigarettes a day on average in the 3 months before the test;
- •Donate blood or blood loss ≥ 400ml within 3 months before taking the study drug;
- •Have a history of surgery or have taken the study drug within 3 months before taking the study drug;
- •Any prescription drugs taken within 14 days before taking the study drug;
- •Any over-the-counter medicines, herbal medicines or prescribe products taken within 7 days before taking the study drug;
- •Have taken a special diet or strenuous exercise or other drugs that affect the study within 48 hours before taking the study drug Those with factors such as absorption, distribution, metabolism, and excretion;
- •Consume chocolate, any caffeine-containing or xanthine-rich beverage or food (such as animal liver) within 48 hours before taking the study drug;
- •Those who have taken any alcohol-containing products within 24 hours before taking the study medication, or those who have been tested positive for alcohol;
- •Subjects judged by other researchers to be unsuitable to participate.
研究组 & 干预措施
CuminUP60®,then Curcumin capsules
Participants first received CuminUP60® 1600mg on the first day in a fasting state.After a washout period of 7days,they then received curcumin capsules 1600mg on the eighth day in a fasting state.
干预措施: CuminUP60® (Drug)
CuminUP60®,then Curcumin capsules
Participants first received CuminUP60® 1600mg on the first day in a fasting state.After a washout period of 7days,they then received curcumin capsules 1600mg on the eighth day in a fasting state.
干预措施: Curcumin capsules (Drug)
Curcumin capsules,then CuminUP60®
Participants first received curcumin capsules 1600mg on the first day in a fasting state.After a washout period of 7days,they then received CuminUP60® 1600mg on the eighth day in a fasting state.
干预措施: CuminUP60® (Drug)
Curcumin capsules,then CuminUP60®
Participants first received curcumin capsules 1600mg on the first day in a fasting state.After a washout period of 7days,they then received CuminUP60® 1600mg on the eighth day in a fasting state.
干预措施: Curcumin capsules (Drug)
结局指标
主要结局
AUC（AUC0-t，AUC0-∞）
时间窗: Day 0 to Day 3
Area under the plasma concentration versus time curve
Tmax
时间窗: Day 0 to Day 3
Time of Cmax
Cmax（Peak Plasma Concentration ）
时间窗: Day 0 to Day 3
Maximum observed concentration,occurring at Tmax
F
时间窗: Day 0 to Day 3
The rate and extent at which a drug is absorbed into the circulation of the body
次要结局
- tl/2(Day 0 to Day 3)
- λz(Day 0 to Day 3)