NCT06386211

Bioavailability Study of Magne-B6 New Formulation

Name: Clinical Trial NCT06386211
Creator: Opella Healthcare Group SAS, a Sanofi Company
Keywords: Healthy Volunteers, MAGNE-B6 Oral Solution, Phase 1, drug, clinical trial

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.

Opella Healthcare Group SAS, a Sanofi Company·Phase 1·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Healthy Volunteers
Drug/Device/Intervention: MAGNE-B6 Oral Solution
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Opella Healthcare Group SAS, a Sanofi Company
Funder: Sanofi

Timeline & enrollment

Phase: Phase 1
Start date: May 06, 2024
End date: Jun 15, 2024
Enrollment: 24 participants

Primary outcome

Maximal Observed Concentration (Cmax) of Magnesium in Plasma,Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma,Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma,Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma,Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma,Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma,Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma,Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma,Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine

Summary

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

ICD-10 classifications

Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06386211
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06386211 through Pure Global AI's free database. This Phase 1 trial is sponsored by Opella Healthcare Group SAS, a Sanofi Company and is currently Not yet recruiting. The study focuses on Healthy Volunteers. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.