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

NCT01935570 | Completed Phase 1

• 1 other identifier: CHU-0162
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Keywords

Bioavailability of magnesium; Digestive and general tolerance

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Adverse digestive events record

  T0+24 hours

Study Arms (1)

Magnesium

EXPERIMENTAL

Drug: Magnesium chloride (ChronoMag Smart Tablet®); Drug: Magnesium carbonate (Mag2® Tablet)

Interventions

Magnesium chloride (ChronoMag Smart Tablet®) DRUG

Magnesium

Magnesium carbonate (Mag2® Tablet) DRUG

Magnesium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Dr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501): collaborator
• Dr Gilles DUCHEIX (Attaché)(Clinical Pharmacology center, Inserm 501): collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Magnesium Chloride; magnesium carbonate

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Magnesium Compounds

Study Officials

• Christian DUALE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: September 5, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

FR (1)