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

Healthy Volunteers Clinical Trial

— BioChronoMag  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935570
• Other study ID #: CHU-0162
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2013
• Last updated: July 3, 2015
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Magnesium chloride (ChronoMag Smart Tablet®)

• Magnesium carbonate (Mag2® Tablet)

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Dr Gilles DUCHEIX (Attaché)(Clinical Pharmacology center, Inserm 501), Dr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood magnesium concentration		T0, T0+30 minutes, T0+1h, T0+2h, T0+3h, T0+4h, T0+5h, T0+6h, T0+7h, T0+8h).	Yes
Primary	urine magnesium concentration		T0+5h , T0+10h , T0+24h	Yes
Secondary	Adverse digestive events record		T0+24 hours	Yes