Healthy VolunteersPhase 1NCT06386211

Bioavailability Study of Magne-B6 New Formulation

A Phase 1 study testing MAGNE-B6 Oral Solution and MAGNE-B6 New Formulation Tablet in people with Healthy Volunteers, run by Opella Healthcare Group SAS, a Sanofi Company at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: MAGNE-B6 Oral Solution and MAGNE-B6 New Formulation Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 3 Jul 2024to 24 Aug 2024
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female participants, between 18 and 45 years of age, inclusive.
Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive.
Females of childbearing potential (pre-menopausal female biologically capable of becoming pregnant) or not documented post-menopausal (menopause is defined as being amenorrheic for at least 1 year with plasma follicle stimulating hormone [FSH] level >30 International units per liter [UI/L]) who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last IMP administration:
Intra-uterine contraceptive device placed at least 4 weeks prior to IMP administration.
Male condom with intravaginally applied spermicide starting at least 21 days prior to investigational medicinal product (IMP) administration.
Hormonal contraceptives starting at least 4 weeks prior to IMP administration and must agree to use the same hormonal contraceptive throughout the study.

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Sterile male partner (vasectomized since at least 6 months).
Abstaining from sexual intercourse.
Male participant, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, an adequate contraception for study period duration or abstaining from sexual intercourse.
Presenting normal magnesemia (0.65-1.05 millimolar [mM]).
Presenting normal plasma level of vitamin B6 (20-50 nanomolar [nM]).
Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
Vital signs after 10 minutes resting in supine position within the following range:
Systolic blood pressure (SBP): 100 - 130 millimeters of mercury (mmHg)
Diastolic blood pressure (DBP): 60 - 90 mmHg
Heart rate (HR): 60 -90 beats per minute (bpm).
Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges: 120 milliseconds (ms)<PQ<200 ms, 60 ms <QRS<100 ms, QTcF from 340 ms to 450 ms inclusive and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
Laboratory parameters within the normal range.
Having given written informed consent prior to undertaking any study-related procedure.
Not under any administrative or legal supervision

Who cannot join

Lactase deficiency, lactose intolerance; glucose-galactose malabsorption; acute infectious diseases or allergic reaction requiring treatment (including drug allergies) within 4 weeks prior to the screening; a history of gastrointestinal tract surgery (except appendectomy).
Depot injections, installation of intrauterine hormonal therapeutic systems or implants of any drugs 6 months before the first day of screening.
Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
Participants experiencing stress, especially severe stress, anxiety, post-trauma or social anxiety disorder, or depression would be excluded.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.

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Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
For women: using hormonal contraceptives less than 2 months before the first day of screening.
Participants receiving hormonal replacement therapy (incl. surgical menopause).
Any medication, vitamin, biologically active additives, herbal preparations (including St John's Wort, angelica, evening primrose, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng, etc.) within 30 days before inclusion any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before screening.
Any intake of aluminum-and-magnesium-containing antacids within 14 days before Period I.
Any drug containing Magnesium or B6 vitamin within 14 days before Period I.
Any tricyclic antidepressants within 14 days before Period I.
Deviations of laboratory test results from reference intervals standard laboratory and instrumental examination methods.
Any diet, such as vegetarian, within 2 weeks of the first day of screening.
Not being able to go without food for at least 12 hours and not being able to take the drug on an empty stomach.
Volunteers expected to have problems with venous catheterization or venipuncture.
Volunteers unwilling or unable to give up alcohol and excessive exercise from the first day of screening to the follow-up visit.
Volunteers with lifestyles (including night work and extreme physical activity such as sports or weightlifting) that can make it difficult to interpret laboratory findings from the study.
Volunteers who are unwilling to observe the requirements of the study and / or unreliable, volunteers who, in the Investigator's opinion, are apparently or probably unable to understand and assess information concerning this study before the signing of the Informed Consent Form, in particular in relation to anticipated risks and potential discomforts.
Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
Participation in any other clinical trial or study drug intake less than 3 months before the first day of screening.
Any participant who cannot be contacted in case of emergency.
Any participant who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
Any consumption of citrus fruits (grapefruit, orange, etc.) or their juices, as well as all fruit juices, within 5 days before Period I.
Alcohol consumption more than 10 units alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of wine or 50 ml of spirits) or history of alcoholism, drug addiction, drug abuse.
Smoking regularly more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), or breast-feeding.
Premenstrual syndrome
Climacteric syndrome (incl. surgical menopause) not receiving hormonal replacement therapy.
Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus antibodies (anti-HIV Ab).
Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
Positive alcohol breath test.
Presence or history of hypersensitivity to any presentation of Magne-B6 or to any of the excipients.
Participants presenting one or several symptoms of magnesium deficiencies as listed in the Magne-B6 summary of product characteristic (SmPC).
Any contraindications to Magne-B6, according to the applicable labeling.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erciyes Universitesi Hakan Cetinsaya Iyi Klinik Uygulama ve Araştırma Merkezi Erciyes Universitesi Kampusu
Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: Open-label, Randomized, 2-treatment, 2-sequence, 2-period, Crossover Relative Bioavailability Study of Magne-B6 New Formulation Versus Magne-B6 Solution in Healthy Male and Female Subjects in Fasting Conditions.

The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions.

Conditions: Healthy Volunteers
Being tested: MAGNE-B6 Oral Solution, MAGNE-B6 New Formulation Tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAGNE-B6 Oral SolutionDrug
Oral solution.
MAGNE-B6 New Formulation TabletDrug
New formulation tablet.

Study groups in NCT06386211
Study group	Role	What they receive
Treatment Sequence Group 1	Experimental	Not described Receives: Drug: MAGNE-B6 Oral Solution; Drug: MAGNE-B6 New Formulation Tablet
Treatment Sequence Group 2	Experimental	Not described Receives: Drug: MAGNE-B6 Oral Solution; Drug: MAGNE-B6 New Formulation Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximal Observed Concentration (Cmax) of Magnesium in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine
Measured: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2

Secondary outcomes (1)

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
A TEAE is defined as an AE that occurred or worsened at any time during the on-treatment phase.
Measured: From screening up to 3 days after last administration (approximately 7 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 202424 Aug 2024

First posted26 Apr 2024
Study start3 Jul 2024
Primary completion24 Aug 2024
Study completion24 Aug 2024

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.
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: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06386211
Sponsor's protocol ID: BDR17228
Other IDs: BDR17228
Status last verified: Sep 2025
First submitted: 23 Apr 2024
Last updated: 12 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Randomized, 2-treatment, 2-sequence, 2-period, Crossover Relative Bioavailability Study of Magne-B6 New Formulation Versus Magne-B6 Solution in Healthy Male and Female Subjects in Fasting Conditions.
ClinicalTrials.gov ID: NCT06386211
Acronym / sponsor ID: BDR17228
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Opella Healthcare Group SAS, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 3 Jul 2024 (actual)
Primary completion: 24 Aug 2024 (actual)
Study completion: 24 Aug 2024 (actual)
First posted: 26 Apr 2024 (actual)
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.

The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment Sequence Group 1	Experimental	Drug: MAGNE-B6 Oral Solution, Drug: MAGNE-B6 New Formulation Tablet
Treatment Sequence Group 2	Experimental	Drug: MAGNE-B6 Oral Solution, Drug: MAGNE-B6 New Formulation Tablet

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (20 listed)

Male or female participants, between 18 and 45 years of age, inclusive.
Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive.
Females of childbearing potential (pre-menopausal female biologically capable of becoming pregnant) or not documented post-menopausal (menopause is defined as being amenorrheic for at least 1 year with plasma follicle stimulating hormone [FSH] level >30 International units per liter [UI/L]) who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last IMP administration:
Male participant, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, an adequate contraception for study period duration or abstaining from sexual intercourse.
Presenting normal magnesemia (0.65-1.05 millimolar [mM]).

Key exclusion criteria (38 listed)

Lactase deficiency, lactose intolerance; glucose-galactose malabsorption; acute infectious diseases or allergic reaction requiring treatment (including drug allergies) within 4 weeks prior to the screening; a history of gastrointestinal tract surgery (except appendectomy).
Depot injections, installation of intrauterine hormonal therapeutic systems or implants of any drugs 6 months before the first day of screening.
Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
Participants experiencing stress, especially severe stress, anxiety, post-trauma or social anxiety disorder, or depression would be excluded.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).

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
MAGNE-B6 Oral SolutionOral solution.	Drug	Treatment Sequence Group 1, Treatment Sequence Group 2
MAGNE-B6 New Formulation TabletNew formulation tablet.	Drug	Treatment Sequence Group 1, Treatment Sequence Group 2

Primary outcome

Maximal Observed Concentration (Cmax) of Magnesium in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine
Time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2

1 secondary outcome

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From screening up to 3 days after last administration (approximately 7 weeks)

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 12 Sep 2025.
BDR17228 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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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.

CHC Clinical studies study director

Opella Healthcare Group SAS, a Sanofi Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 inclusion and 38 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 12 Sep 2025. 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 Turkey (Türkiye). 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?

Maximal Observed Concentration (Cmax) of Magnesium in Plasma (time frame: Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06386211.

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 12 Sep 2025.