Sotagliflozin Bioequivalence Study
- Registration Number
- NCT03211195
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects.
Secondary Objectives:
* To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test) tablet or a single sotagliflozin (reference) table in healthy male and female subjects under fasting conditions.
* To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet compared to a single sotagliflozin (reference) tablet administered under fasted conditions in healthy male and female subjects.
- Detailed Description
The study duration per subject will be 36-99 days and will consist of a screening period of 2 to 21 days, a study period of 7 days for each of four periods, and a washout of 8-21 days between each dose administration, and a final follow up visit 10-15 days after final dose administration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sotagliflozin - Commerical Sotagliflozin (SAR439954) Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Commercial formulation) by mouth under fasted conditions Sotagliflozin -Development Sotagliflozin (SAR439954) Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Development formulation) by mouth under fasted conditions - Type: Active Comparator
- Primary Outcome Measures
Name Time Method Assessment of PK parameter: AUClast From 0 to 120 hours after SAR439954 intake Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Assessment of PK (pharmacokinetic) parameter: Cmax From 0 to 120 hours after SAR439954 intake Sotagliflozin: Maximum plasma concentration (Cmax)
Assessment of PK parameter: AUC From 0 to 120 hours after SAR439954 intake Sotagliflozin: Area under the concentration-time curve from 0 to infinity
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter: t1/2 From 0 to 120 hours after SAR439954 intake Sotagliflozin 3-O-glucuronide: Terminal elimination half life (T1/2)
Assessment of PK parameter: Vz/F From 0 to 120 hours after SAR439954 intake Sotagliflozin: Apparent volume of distribution during terminal phase after non-intravenous administration Vz/F
Assessment of PK parameter: Tmax From 0 to 120 hours after SAR439954 intake Sotagliflozin 3-O-glucuronide: Time to reach maximum plasma concentration (Cmax)
Assessment of PK parameter: CL/F From 0 to 120 hours after SAR439954 intake Sotagliflozin: Apparent total body clearance of a drug from the plasma (CL/F)
Assessment of PK parameter: Cmax From 0 to 120 hours after SAR439954 intake Sotagliflozin 3-O-glucuronide: Maximum plasma concentration (Cmax)
Assessment of PK parameter: AUC From 0 to 120 hours after SAR439954 intake Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to infinity
Assessment of PK parameter: AUClast From 0 to 120 hours after SAR439954 intake Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Treatment emergent adverse events (TEAE) From 0 to 144 hours after SAR439954 intake Number treatment emergent adverse events
Trial Locations
- Locations (1)
Investigational Site Number 840001
🇺🇸Miami, Florida, United States