Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- blood magnesium concentration
研究概览
简要总结
This clinical study is composed of two steps. The first step aims at validating the pharmacokinetic approach based on the magnesium concentration in erythrocyte and plasma.
According to these results and if this pharmacokinetic approach is validated, the second step will set up. The second phase aims at comparing the relative bioavailability of magnesium administrated by two different drug formulations: ChronoMag Smart Tablet® (two tablets50mg) versus Mag2® (three tablets100mg).
详细描述
" Go/no go " comparative biodisponibility study. Randomised, cross-over, controlled and double-blind, monocentric study in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •Patient aged between 18 and 50
- •Patient with a normal blood magnesium rate between 0.65 and 1.05 mmol/l
- •Patient with vital signs values considered as normal by the investigator before drug administration
- •Sufficient cooperation and understanding to comply with the requirements of study.
- •Patient without medication during the 7 days preceding the inclusion
- •Acceptance to give a written consent.
- •Affiliation at system of French social security.
- •Inscription or acceptation of inscription at national register of voluntaries participant at research.
排除标准
- •Against magnesium-indication: hypersensitivity known at carbonate or magnesium chloride or at one of the excipients.
- •Patient with medication or supplementation of magnesium
- •Severe renal insufficiency with a creatine clearance ≤ 30ml/min
- •Medical and chirurgical history considered as incompatible with the study
- •A progressive pathology during the inclusion
- •A consumption of more than 50g of dark chocolate per day
- •An excessive alcohol consumption, an excessive tobacco consumption ( more than 10 cigarettes a day), an excessive tea, coffee or drink with caffeine consumption or drug addictions
- •Patient who participated in another clinical trial located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial.
- •Patient with cooperation and understanding insufficiency to comply with the requirements of protocol
- •Minor or patient with social protection (curatorship, tutorship...)
- •No affiliation at system of French social security
研究组 & 干预措施
Magnesium
干预措施: Magnesium chloride (ChronoMag Smart Tablet®) (Drug)
Magnesium
干预措施: Magnesium carbonate (Mag2® Tablet) (Drug)
结局指标
主要结局
blood magnesium concentration
时间窗: T0, T0+30 minutes, T0+1h, T0+2h, T0+3h, T0+4h, T0+5h, T0+6h, T0+7h, T0+8h).
urine magnesium concentration
时间窗: T0+5h , T0+10h , T0+24h
次要结局
- Adverse digestive events record(T0+24 hours)