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Completed

NCT Number: NCT01935570

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

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).

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium chloride (ChronoMag Smart Tablet®)

Drug

Magnesium carbonate (Mag2® Tablet)

Drug

Primary outcomes

  1. 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).

  2. urine magnesium concentration

    Time frame: T0+5h , T0+10h , T0+24h

Secondary outcomes

  1. Adverse digestive events record

    Time frame: T0+24 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

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

Registry information

Acronym: BioChronoMag

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2013
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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