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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Magnesium chloride (ChronoMag Smart Tablet®); Drug: Magnesium carbonate (Mag2® Tablet)

• Registration Number: NCT01935570
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2013-07-02
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnesium	Magnesium chloride (ChronoMag Smart Tablet®)	-
Magnesium	Magnesium carbonate (Mag2® Tablet)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse digestive events record	T0+24 hours

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France