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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number 840001
Miami, Florida, United States
Assessment of PK (pharmacokinetic) parameter: Cmax
Sotagliflozin: Maximum plasma concentration (Cmax)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: AUClast
Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: AUC
Sotagliflozin: Area under the concentration-time curve from 0 to infinity
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: Tmax
Sotagliflozin: Time to reach maximum plasma concentration (Tmax)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: t1/2
Sotagliflozin: Terminal elimination half life (T1/2)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: Vz/F
Sotagliflozin: Apparent volume of distribution during terminal phase after non-intravenous administration Vz/F
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: CL/F
Sotagliflozin: Apparent total body clearance of a drug from the plasma (CL/F)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: Cmax
Sotagliflozin 3-O-glucuronide: Maximum plasma concentration (Cmax)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: AUC
Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to infinity
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: AUClast
Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: Tmax
Sotagliflozin 3-O-glucuronide: Time to reach maximum plasma concentration (Cmax)
Time frame: From 0 to 120 hours after SAR439954 intake
Assessment of PK parameter: t1/2
Sotagliflozin 3-O-glucuronide: Terminal elimination half life (T1/2)
Time frame: From 0 to 120 hours after SAR439954 intake
Treatment emergent adverse events (TEAE)
Number treatment emergent adverse events
Time frame: From 0 to 144 hours after SAR439954 intake
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