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

July 3, 2015 updated by: University Hospital, Clermont-Ferrand

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium
Drug: Magnesium chloride (ChronoMag Smart Tablet®)
Drug: Magnesium carbonate (Mag2® Tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood magnesium concentration
Time Frame: T0, T0+30 minutes, T0+1h, T0+2h, T0+3h, T0+4h, T0+5h, T0+6h, T0+7h, T0+8h).
T0, T0+30 minutes, T0+1h, T0+2h, T0+3h, T0+4h, T0+5h, T0+6h, T0+7h, T0+8h).
urine magnesium concentration
Time Frame: T0+5h , T0+10h , T0+24h
T0+5h , T0+10h , T0+24h

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse digestive events record
Time Frame: T0+24 hours
T0+24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 3, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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