A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions

• Status: Completed
• Trial end date: 2019-04-22

Summary

Primary Objective:

To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects

Secondary Objectives:

• To evaluate the single-dose pharmacokinetics of sotagliflozin following administration of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) in healthy male and female subjects under fasting conditions

• To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) administered under fasted conditions in healthy male and female subjects

• Phase: Phase 1

Details

• Lead Sponsor: Sanofi
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol