NCT05419466已完成不适用
Kinetic of Plasmatic Compounds and Metabolites of a Melatonin-based Formulation in Healthy Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Larena SAS
- 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 and zinc bioavailability of a dietary supplement containing delayed release melatonin, zinc and lemon balm
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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,
- •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 zinc or a product containing it 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, rifampicin, analgesics, Liver abnormality known or detected at the screening visit and judged to be clinically significant by the investigator, Known autoimmune disease,
- •Any condition that could involve zinc deficiency or hyperzincemia: Medication intake: penicillamine or diuretics, Poisoning by exposure to zinc (zinc mines, zinc metallurgy, galvanizing operations, manufacture of alloys, use of zinc-based pigments and salts, etc.), Pick's disease, malabsorption (pancreatic insufficiency, biliary obstruction, gastrectomy, jejuno-ileostomy, intestinal diverticulum, tropical sprue, celiac disease, cystic fibrosis), intestinal inflammation (enteropathy with protein leakage, inflammatory colitis), liver disorders (cirrhosis, hepatitis) , kidney disorders (chronic renal failure, nephrotic syndrome), neuropsychiatric disorders (anorexia nervosa, endogenous depression, alcoholism), genetic diseases (acrodermatitis enteropathica, thalassemia, sickle cell disease, diabetes, trisomy 21, phenylketonuria), parasitic diseases (ankylostomiasis, schistosomiasis, malaria , giardiasis)
- •Subject assessed as "rather" or "definitely" among evening people,
- •Epileptic subject,
- •Asthmatic subject,
- •Known hypertension (>140/90),
- •Diagnosis of migraine by a health professional according to the International Headache Society (IHS) criteria revised in 2004,
- •With 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: Up to 720 minutes after taking the tablet
The change in plasma melatonin concentration
次要结局
- Plasma 6-sulfatoxymelatonin AUC(Up to 720 minutes after taking the tablet)
- Plasma 6-sulfatoxymelatonin Cmax(Up to 720 minutes after taking the tablet)
- Plasma 6-sulfatoxymelatonin half life(Up to 720 minutes after taking the tablet)
- Plasma zinc Cmax(Up to 720 minutes after taking the tablet)
- Evolution of state of drowsiness(Up to 720 minutes after taking the tablet)
- Plasma melatonin Tmax(Up to 720 minutes after taking the tablet)
- Plasma melatonin half life(Up to 720 minutes after taking the tablet)
- Evolution of the plasma concentration of 6-sulfatoxymelatonin(Up to 720 minutes after taking the tablet)
- Plasma 6-sulfatoxymelatonin Tmax(Up to 720 minutes after taking the tablet)
- Evolution of the plasma zinc concentration(Up to 720 minutes after taking the tablet)
- Plasma zinc AUC(Up to 720 minutes after taking the tablet)
- Plasma zinc half life(Up to 720 minutes after taking the tablet)
- Plasma melatonin AUC(Up to 720 minutes after taking the tablet)
- Plasma melatonin Cmax(Up to 720 minutes after taking the tablet)
- Plasma zinc Tmax(Up to 720 minutes after taking the tablet)
- Adverse events(During study participation, maximum 45 days)
研究者
研究点 (2)
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