A Phase 1 interventional study of MAGNE-B6 Oral Solution and MAGNE-B6 New Formulation Tablet in Healthy Volunteers, sponsored by Opella Healthcare Group SAS, a Sanofi Company. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Opella Healthcare Group SAS, a Sanofi Company · Phase 1, Interventional, and Treatment
The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions.
Opella Healthcare Group SAS, a Sanofi Company is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Vital signs after 10 minutes resting in supine position within the following range:
Exclusion Criteria:
Drug: MAGNE-B6 Oral Solution · Drug: MAGNE-B6 New Formulation Tablet
Drug: MAGNE-B6 Oral Solution · Drug: MAGNE-B6 New Formulation Tablet
Oral solution.
New formulation tablet.
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
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.
Time frame: From screening up to 3 days after last administration (approximately 7 weeks)
Plan to share: 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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Opella Healthcare Group SAS, a Sanofi Company