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

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Magnesium chloride (ChronoMag Smart Tablet®)

Drug: Magnesium carbonate (Mag2® Tablet)

Study type

Interventional

Funder types

Other

Identifiers

NCT01935570

CHU-0162

Details and patient eligibility

About

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).

Full description

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

Enrollment

17 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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