Healthy VolunteersPhase 1BioChronoMagNCT01935570
Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.
A Phase 1 study testing Magnesium chloride (ChronoMag Smart Tablet®) and Magnesium carbonate (Mag2® Tablet) in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Magnesium chloride (ChronoMag Smart Tablet®) and Magnesium carbonate (Mag2® Tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
" Go/no go " comparative biodisponibility study. Randomised, cross-over, controlled and double-blind, monocentric study in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Magnesium chloride (ChronoMag Smart Tablet®), Magnesium carbonate (Mag2® Tablet)
- Keywords
- Bioavailability of magnesium, Digestive and general tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium chloride (ChronoMag Smart Tablet®)Drug
Magnesium carbonate (Mag2® Tablet)Drug
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | Not described Receives: Drug: Magnesium chloride (ChronoMag Smart Tablet®); Drug: Magnesium carbonate (Mag2® Tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood magnesium concentration
Measured: T0, T0+30 minutes, T0+1h, T0+2h, T0+3h, T0+4h, T0+5h, T0+6h, T0+7h, T0+8h).
urine magnesium concentration
Measured: T0+5h , T0+10h , T0+24h
Secondary outcomes (1)
Adverse digestive events record
Measured: T0+24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501), Dr Gilles DUCHEIX (Attaché)(Clinical Pharmacology center, Inserm 501)
- Responsible party
- Sponsor
- Investigators
- Christian DUALE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935570
- Sponsor's protocol ID
- CHU-0162
- Acronym
- BioChronoMag
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.
- ClinicalTrials.gov ID
- NCT01935570
- Acronym / sponsor ID
- BioChronoMag / CHU-0162
- Conditions
- Healthy Volunteers
- Keywords
- Bioavailability of magnesium, Digestive and general tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Dr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501), Dr Gilles DUCHEIX (Attaché)(Clinical Pharmacology center, Inserm 501)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Drug: Magnesium chloride (ChronoMag Smart Tablet®), Drug: Magnesium carbonate (Mag2® Tablet) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium chloride (ChronoMag Smart Tablet®) | Drug | Magnesium |
| Magnesium carbonate (Mag2® Tablet) | Drug | Magnesium |
Primary outcome
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).
urine magnesium concentration
Time frame: T0+5h , T0+10h , T0+24h
1 secondary outcome
Adverse digestive events record
Time frame: T0+24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian DUALE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magnesium chloride (ChronoMag Smart Tablet®) and Magnesium carbonate (Mag2® Tablet) in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.