Bioavailability Study of Magne-B6 New Formulation - Trial NCT06386211
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.
Study Focus
Sponsor & Location
Opella Healthcare Group SAS, a Sanofi Company
Sanofi
Timeline & Enrollment
Phase 1
May 06, 2024
Jun 15, 2024
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
Data Source
ClinicalTrials.gov
NCT06386211
Non-Device Trial