Healthy Volunteers
Conditions
Keywords
Bioavailability of magnesium, Digestive and general tolerance
Brief summary
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
Go/no go comparative biodisponibility study. Randomised, cross-over, controlled and double-blind, monocentric study in healthy volunteers.
Interventions
DRUGMagnesium chloride (ChronoMag Smart Tablet®)
DRUGMagnesium carbonate (Mag2® Tablet)
Sponsors
Dr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501)
Dr Gilles DUCHEIX (Attaché)(Clinical Pharmacology center, Inserm 501)
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Adverse digestive events record | T0+24 hours |
Countries
France
Outcome results
None listed