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| ID | Type | Description | Link |
|---|---|---|---|
| BDR17228 | Other Identifier | Sanofi Identifier |
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The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence Group 1 | Experimental |
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| Treatment Sequence Group 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAGNE-B6 Oral Solution | Drug | Oral solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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]).
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:
Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges: 120 milliseconds (ms)\
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| Name | Affiliation | Role |
|---|---|---|
| CHC Clinical studies | Opella Healthcare Group SAS, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes Universitesi Hakan Cetinsaya Iyi Klinik Uygulama ve Araştırma Merkezi Erciyes Universitesi Kampusu | Kayseri | 38039 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| BDR17228 Plain Language Results Summary | View source |
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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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| MAGNE-B6 New Formulation Tablet | Drug | New formulation tablet. |
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| 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 |
| From screening up to 3 days after last administration (approximately 7 weeks) |