Bioavailability of Spermidine in Healthy Males
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
研究概览
简要总结
To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence of any Adverse Events/Serious adverse events.
详细描述
Until now, lack of availability of a reproducible high quality, uncontaminated, spermidine for human consumption as a food or supplement has been a significant barrier to its study and use.
Chrysea is producing spermidine by a patented biological process to consistently produce very high purity spermidine to pharmaceutical and food grade standards.
Using a rat ex vivo jejunal absorption model and 14Carbon labelled spermidine, the recovery rate of radioactivity at the portal vein was approximately 61-76% during the initial 10 minutes after the administration of 14C-spermidine.
Data on spermidine absorption in humans is very limited. The purpose of this single blind randomised pharmacokinetic study is to demonstrate absorption of 20mg and 40 mg doses of spermidine in fasted normal volunteers, and to describe the absorption kinetics (Tmax, Cmax, T1/2, AUC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
single blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able to give written informed consent.
- •Age between 18-70 years inclusive.
- •BMI between ≥18.5 and ≤28 kg/m
- •In general good health, as determined by the investigator.
- •Agree to abstain from consuming alcohol, grapefruit, or grapefruit juice for 72 hours prior to visit 2 and visit
- •Adequate vein access for cannulation and multiple blood draws.
- •Able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
- •Willing to consume the study product.
排除标准
- •History of anaphylaxis,
- •Documented hypersensitivity reaction or a clinically important reaction to any dietary/food supplement or drug,
- •Intolerance or sensitivity to study product ingredients
结局指标
主要结局
Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
时间窗: Pre dosing to dosing plus six hours
Maximum concentration of circulating spermidine (Cmax)
AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
时间窗: Pre dosing to dosing plus six hours
Area Under the Curve (AUC)
Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
时间窗: Pre dosing to dosing plus six hours
Time to peak of circulating spermidine (Tmax)
T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males.
时间窗: Pre dosing to dosing plus six hours
Half-life of circulating spermidine (t1/2)
次要结局
未报告次要终点