NCT04574141已完成不适用
Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- evolution of the plasma melatonin concentration
研究概览
简要总结
This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between the ages of 18 and 45,
- •In good general health, i.e., free of chronic conditions and not taking medication at the time of inclusion and/or long-term,
- •Over 70 kg and with a body mass index between 18.5 and 24.9,
- •Able and willing to participate in the research by complying with the procedures of the protocol, in particular concerning the taking of the product under study and the performance of sequential blood tests,
- •Having freely signed the consent form after adequate information on the proposed study, in accordance with Good Clinical Practice and after submission of the information leaflet,
- •Affiliated to a social security scheme or similar.
排除标准
- •Drug addict,
- •Subject with an alcohol consumption of more than 2 glasses per day,
- •Taking a drug treatment or melatonin or a product containing melatonin within 48 hours prior to a kinetics visit,
- •Known organic or functional abnormality of the urinary tree,
- •Any medical condition that would involve a change in melatonin metabolism:
- •Drug intake: Fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, carbamazepine and rifampicin, analgesics, Liver abnormality known or detected at the screening visit and judged to be clinically significant by the investigator, Known autoimmune disease,
- •Subject assessed as "moderately" or "definitely" evening type,
- •Known hypertension (>140/90),
- •Diagnosis of migraine by a health professional according to the International Headache Society (IHS) criteria revised in 2004,
- •Wuth a sleep disorder,
- •Thyroid dysfunction, hyperglycemia or anemia judged to be clinically significant by the investigator,
- •Blood donation within one month prior to inclusion,
- •A known organic or psychological abnormality (including a history of severe depression) that may bias the results of the study as judged by the investigator,
- •Workers with atypical working hours (night work, staggered working hours),
- •Known allergy or intolerance to any of the components of the product,
- •Psychological or linguistic inability to understand and sign informed consent,
- •Participant in another interventional clinical trial or during a period of exclusion from a previous clinical trial,
- •Under legal protection (guardianship, curatorship) or deprived of his rights as a result of the administrative or judicial decision,
- •Subject who has reached the maximum threshold for compensation for research provided for in the regulations.
结局指标
主要结局
evolution of the plasma melatonin concentration
时间窗: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
the change in plasma melatonin concentration
次要结局
- adverse events(during study participation, maximum 45 days)
- salivary melatonin AUC(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- urinary 6-sulfatoxymelatonin Cmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma 6-sulfatoxymelatonin Tmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- evolution of the urinary concentration of 6-sulfatoxymelatonin(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma melatonin AUC(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma melatonin Cmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma 6-sulfatoxymelatonin Cmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- salivary melatonin Cmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- evolution of the plasma concentration of 6-sulfatoxymelatonin(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- evolution of the salivary concentration of melatonin(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- urinary 6-sulfatoxymelatonin AUC(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma melatonin Tmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma 6-sulfatoxymelatonin AUC(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma melatonin half life(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- urinary 6-sulfatoxymelatonin half life(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- salivary melatonin half life(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- urinary 6-sulfatoxymelatonin Tmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- salivary melatonin Tmax(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
- plasma 6-sulfatoxymelatonin half life(over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.)
研究者
研究点 (2)
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