Bioavailability Study of Magne-B6 New Formulation

NCT06386211 | Completed Phase 1

• 1 other identifier: BDR17228
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (9)

• Maximal Observed Concentration (Cmax) of Magnesium in Plasma

  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

  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

  Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2

• Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma

  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

  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

  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

  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

  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

  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)

  From screening up to 3 days after last administration (approximately 7 weeks)

Study Arms (2)

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

Interventions

MAGNE-B6 Oral Solution DRUG

Oral solution.

Treatment Sequence Group 1; Treatment Sequence Group 2

MAGNE-B6 New Formulation Tablet DRUG

New formulation tablet.

Treatment Sequence Group 1; Treatment Sequence Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• Opella Healthcare Group SAS, a Sanofi Company: lead

Study Sites (1)

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

Kayseri, 38039, Turkey (Türkiye)

Location

Related Links

• BDR17228 Plain Language Results Summary

Study Officials

• CHC Clinical studies

  Opella Healthcare Group SAS, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: July 3, 2024
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)