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Magne-B6 gets a makeover: new tablet tested against old liquid

NCT ID NCT06386211

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study tested whether a new tablet form of Magne-B6 releases magnesium and vitamin B6 into the body as well as the current liquid version. Twenty-four healthy adults took both forms in random order and had their blood and urine levels measured. The goal was to see if the tablet could be a good alternative to the liquid.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Magne-B6 (magnesium and pyridoxine)
What this could lead to
If the new tablet works as well as the solution, it could offer a more convenient way to take Magne-B6.
What could go wrong
This is a small, early-stage study in healthy volunteers, so results may not apply to people with medical conditions. The new tablet might not absorb as well as the solution.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Jul 2024

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female participants, between 18 and 45 years of age, inclusive. 2. 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. 3. 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. * Sterile male partner (vasectomized since at least 6 months). * Abstaining from sexual intercourse. 4. 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. 5. Presenting normal magnesemia (0.65-1.05 millimolar \[mM\]). 6. Presenting normal plasma level of vitamin B6 (20-50 nanomolar \[nM\]). 7. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). 8. 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). 9. 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. 10. Laboratory parameters within the normal range. 11. Having given written informed consent prior to undertaking any study-related procedure. 12. Not under any administrative or legal supervision Exclusion Criteria: 1. 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). 2. Depot injections, installation of intrauterine hormonal therapeutic systems or implants of any drugs 6 months before the first day of screening. 3. 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. 4. Participants experiencing stress, especially severe stress, anxiety, post-trauma or social anxiety disorder, or depression would be excluded. 5. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). 6. 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. 7. 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. 8. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. 9. For women: using hormonal contraceptives less than 2 months before the first day of screening. 10. Participants receiving hormonal replacement therapy (incl. surgical menopause). 11. 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. 12. Any intake of aluminum-and-magnesium-containing antacids within 14 days before Period I. 13. Any drug containing Magnesium or B6 vitamin within 14 days before Period I. 14. Any tricyclic antidepressants within 14 days before Period I. 15. Deviations of laboratory test results from reference intervals standard laboratory and instrumental examination methods. 16. Any diet, such as vegetarian, within 2 weeks of the first day of screening. 17. Not being able to go without food for at least 12 hours and not being able to take the drug on an empty stomach. 18. Volunteers expected to have problems with venous catheterization or venipuncture. 19. Volunteers unwilling or unable to give up alcohol and excessive exercise from the first day of screening to the follow-up visit. 20. 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. 21. 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. 22. 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. 23. Participation in any other clinical trial or study drug intake less than 3 months before the first day of screening. 24. Any participant who cannot be contacted in case of emergency. 25. 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. 26. Any consumption of citrus fruits (grapefruit, orange, etc.) or their juices, as well as all fruit juices, within 5 days before Period I. 27. 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. 28. Smoking regularly more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. 29. Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). 30. If female, pregnancy (defined as positive beta-human chorionic gonadotropin \[β-HCG\] blood test), or breast-feeding. 31. Premenstrual syndrome 32. Climacteric syndrome (incl. surgical menopause) not receiving hormonal replacement therapy. 33. 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). 34. Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). 35. Positive alcohol breath test. 36. Presence or history of hypersensitivity to any presentation of Magne-B6 or to any of the excipients. 37. Participants presenting one or several symptoms of magnesium deficiencies as listed in the Magne-B6 summary of product characteristic (SmPC). 38. Any contraindications to Magne-B6, according to the applicable labeling.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Erciyes Universitesi Hakan Cetinsaya Iyi Klinik Uygulama ve Araştırma Merkezi Erciyes Universitesi Kampusu

    Kayseri, 38039, Turkey (Türkiye)

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