Comparative Study of the Bioavailability of Magnesium Adm... | NCT01935570

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 2, 2013

First Submission Date that Met QC Criteria

Sep 2, 2013

First Posted Date

Sep 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2015

Last Update Posted Date

Jul 7, 2015Estimated

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

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Label	Type	Description	Intervention Names
Magnesium	Experimental		Drug: Magnesium chloride (ChronoMag Smart Tablet®) Drug: Magnesium carbonate (Mag2® Tablet)

Name	Type	Description	Arm Group Labels	Other Names
Magnesium chloride (ChronoMag Smart Tablet®)	Drug		Magnesium
Magnesium carbonate (Mag2® Tablet)

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Adverse digestive events record		T0+24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D015636	Magnesium Chloride
C005479	magnesium carbonate

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017616	Magnesium Compounds