Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.

Study Overview
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Brief Summary
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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).

Detailed Description
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 Go/no go  comparative biodisponibility study. Randomised, cross-over, controlled and double-blind, monocentric study in healthy volunteers.

Official Title
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Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Magnesium chloride (ChronoMag Smart Tablet®)
* Drug: Magnesium carbonate (Mag2® Tablet)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br> | Drug: Magnesium chloride (ChronoMag Smart Tablet®)<br> <br> Drug: Magnesium carbonate (Mag2® Tablet)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood magnesium concentration |  | T0, T0+30 minutes, T0+1h, T0+2h, T0+3h, T0+4h, T0+5h, T0+6h, T0+7h, T0+8h). | 
| urine magnesium concentration |  | T0+5h , T0+10h , T0+24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse digestive events record |  | T0+24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability of magnesium, Digestive and general tolerance