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

NCT ID: NCT01935570

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Magnesium

Group Type: EXPERIMENTAL

Magnesium chloride (ChronoMag Smart Tablet®)

Intervention Type: DRUG

Magnesium carbonate (Mag2® Tablet)

Intervention Type: DRUG

Interventions

Magnesium chloride (ChronoMag Smart Tablet®)

Intervention Type: DRUG

Magnesium carbonate (Mag2® Tablet)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501)

UNKNOWN

Sponsor Role: collaborator

Dr Gilles DUCHEIX (Attaché)(Clinical Pharmacology center, Inserm 501)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian DUALE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

CHU-0162

Identifier Type: -

Identifier Source: org_study_id